Showing posts with label Allied Health. Show all posts
Showing posts with label Allied Health. Show all posts

Estridge: Basic Clinical Laboratory Techniques 6th Edition

This book teaches prospective laboratory workers and allied health care professionals the basics of clinical laboratory procedures and the theories behind them. Performance-based to maximize hands-on learning, this "work-text" includes step-by-step instruction and worksheets to help users understand laboratory tests and procedures ranging from specimen collection and analysis, to instrumentation and CLIA and OSHA safety protocols. Students and working professionals alike will find Basic Clinical Laboratory Techniques 6th Edition an easy-to-understand, reliable resource for developing and refreshing key laboratory skills.

Contents
  • List of Figures and Tables.
  • Preface.
  • How to Use This Book.
Unit I: INTRODUCTION TO THE CLINICAL LABORATORY.
  • The Clinical Laboratory.
  • The Clinical Laboratory Professional.
  • Medical Terminology.
  • Laboratory Safety: Physical and Chemical Hazards.
  • Laboratory Safety: Biological Hazards.
  • General Laboratory Equipment.
  • The Metric System.
  • Preparing Laboratory Reagents.
  • Quality Assessment.
  • The Microscope.
  • Capillary Puncture.
  • Routine Venipuncture.
Unit II: BASIC HEMATOLOGY.
  • Introduction to Hematology.
  • Hemoglobin. Microhematocrit.
  • The Hemacytometer.
  • Manual RBC and WBC Counts.
  • Platelet Count.
  • Preparing and Staining a Blood Smear.
  • Normal Blood Cell Morphology.
  • White Blood Cell Differential Count.
  • Principles of Automated Hematology.
  • Abnormalities in Peripheral Blood Cell Morphology.
  • Reticulocyte Count.
  • Erythrocyte Sedimentation Rate.
Unit III: BASIC HEMOSTASIS.
  • Principles of Hemostasis.
  • Disorders of Hemostasis.
  • Coagulation Testing Methods.
  • Prothrombin Time.
  • Activated Partial Thromboplastin Time.
  • D-Dimer.
Unit IV: BASIC IMMUNOLOGY AND IMMUNOHEMATOLOGY.
  • Introduction to Immunology.
  • Infectious Mononucleosis Tests.
  • Test for Rheumatoid Factors.
  • Urine hCG Tests.
  • Introduction to Immunohematology.
  • ABO Grouping.
  • Rh Typing.
Unit V: URINALYSIS.
  • Introduction to Urinalysis.
  • Urine Collection and Processing.
  • Physical Examination of Urine.
  • Chemical Examination of Urine.
  • Microscopic Examination of Urine Sediment.
Unit VI: BASIC CLINICAL CHEMISTRY.
  • Introduction to Clinical Chemistry.
  • Principles of Chemistry Instrumentation.
  • Chemistry Specimen Collection and Processing.
  • Point-of-Care Testing.
  • Blood Glucose and Hemoglobin A1c.
  • Blood Cholesterol and Triglycerides.
  • Electrolytes.
  • Fecal Occult Blood.
Unit VII: BASIC CLINICAL MICROBIOLOGY.
  • Introduction to Clinical Microbiology.
  • Microbiology Specimen Collection and Processing.
  • Culture Techniques for Bacteriology.
  • The Gram Stain.
  • Tests for Group A Streptococcus.
  • Urine Culture and Colony Count. Bacterial Identification and Antibiotic Susceptibility Testing.
  • Tests for Sexually Transmitted Diseases.
  • Infection Prevention in Health-Care Settings.
  • Public Health Issue: Emerging Infectious Diseases.
  • Public Health Issue: Biological Threats.
Unit VIII: BASIC PARASITOLOGY.
  • Introduction to Parasitology.
  • Collecting and Processing of Specimens for Parasite Detection.
  • Microscopic Methods of Detecting Intestinal Parasites.
  • Preparing Smears for Blood Parasites.
Glossary.
Appendix A: Guide to Standard Precautions.
Appendix B: Laboratory Reference Values.
Appendix C: Abbreviations and Acronyms Commonly Used in Clinical Laboratories.
Appendix D: Sources of Information: Health Care Accrediting and Credentialing Agencies, Professional Societies, Governmental Agencies.
Index.


Key Features
  • Full-color photographs and illustrations depict the laboratory setting today and aid in visual organization.
  • Colorful graphic icons and in-text features center on safety precautions, critical timing, math skills, quality assurance, and other important issues.
  • Suggested web-based activities and numerous review questions throughout the book reinforce readings and laboratory practice worksheets to let users assess their progress.
  • Since safety is always a priority in clinical settings, these procedures are strongly emphasized throughout the lessons, particularly the safety devices, procedures, and technologies that prevent needle-stick injury.


New to this edition
  • Expanded and updated lessons include all of the best elements of earlier editions--Objectives, Glossary, Review Questions, and Student Performance Guides—along with significant enhancements to every lesson in order to convey the most current accepted practices.
  • Exciting new technologies and instrumentation such as nephelometry, turbidimetry, and automated laboratory transport systems, as well as bar code use on requisition forms, patient I.D. bracelets, and patient specimens, have all been added.
  • Appealing visual enhancements including new photomicrographs of normal and abnormal blood cells add interest to the study of blood cell morphology, while many new tables and graphs for deeper understanding.
  • All-new specimen lessons include chemistry specimen collection and processing, collection of specimens for microbiology, and the use of transport media.
  • Newly added, helpful case studies and critical thinking questions require readers to apply principles from the lesson to solve problems, preparing them for on-the-job decision making.


About the Author
  • Barbara H. Estridge is a retired instructor of medical technology and research associate in the College of Science & Mathematics at Auburn University in Auburn, Alabama. Her experience includes working at the hospital bench, teaching clinical laboratory courses, biological and biomedical research, clinical laboratory management, and more.
  • Anna P. Reynolds is a retired instructor of medical technology and a research coordinator at the College of Agriculture at Auburn University. She taught both hospital and university Medical Technology, Medical Laboratory Technician, and Medical Laboratory Assistant programs. Her experience includes clinical and research experience in hematology, chemistry, urinalysis, microbiology, parasitology, and immunology.


Book Details

  • Paperback: 816 pages
  • Publisher: Delmar Cengage Learning; 6 edition (November 18, 2011)
  • Language: English
  • ISBN-10: 1111138362
  • ISBN-13: 978-1111138363
List Price: $135.95 
 

Lippincott's Visual Nursing 2nd Edition: A Guide to Diseases, Skills, and Treatments

This colorful book for practicing nurses and nursing students provides a unique approach to learning important clinical concepts and techniques. It presents information in a remarkably clear and easy-to-understand fashion, using abundant illustrations to demonstrate hands-on treatments and explain disease pathophysiology. Fully visual text lets the nurse read less and understand more, improving her skills and gaining confidence as a health professional through pictures.


Contents
  • Chapter 1: Basic assessment skills
  • Chapter 2: Cardiovascular care
  • Chapter 3: Respiratory care
  • Chapter 4: Neurologic care
  • Chapter 5: Gastrointestinal care
  • Chapter 6: Musculoskeletal care
  • Chapter 7: Renal and urologic care
  • Chapter 8: Hematologic and immunologic care
  • Chapter 9: Endocrine care
  • Chapter 10: Integumentary care
  • Chapter 11: Female reproductive care
  • Chapter 12 Male reproductive care
  • Index


Key Features
  • Hundreds of color illustrations, photographs, wave forms, diagrams, and more creative visuals
  • Concise, step-by-step instructions to help build nurse's confidence and alleviate fear of hands-on treatments
  • Disease pathophysiology depicted clearly
  • Visual presentation of topics, to make it simple to learn complicated techniques
  • "Lesson Plans" icon signals important information to teach the patient
  • "Picturing Patho" icon points to anatomical illustrations demonstrating what happens when a disease occcurs.
  • "Hands On" icon shows the nurse how to perform nursing procedures and techniques and administer treatments.


New to this edition
  • NEW: Addition of abdominal pressure monitoring skill.
  • NEW: Addition of deep vein thrombosis, superficial vein thrombosis, and peripheral arterial disease.
  • NEW: Peripheral vascular interventions such as aortic aneurysm resection, arterial bypass graft, aortic endovascular stent graft, embolectomy, and vena caval filters.


Product Details

  • Paperback: 512 pages
  • Publisher: Lippincott Williams & Wilkins; Second edition (September 28, 2011)
  • Language: English
  • ISBN-10: 1609136500
  • ISBN-13: 978-1609136505
  • Product Dimensions: 9.9 x 8 x 0.9 inches
List Price: $59.95 
 

Hillier: Aging, the Individual & Society 9th Edition

This accessible text brings a social problems approach to the interdisciplinary study of gerontology. Academic research is combined with an empathetic view of the lives of older people to involve students emotionally and intellectually.


Contents 
  • Preface.
  • 1. Aging in America.
  • 2. Stereotypes and Images.
  • 3. Social and Psychological Theories in Later Life Development.
  • 4. Physical Health and Well Being.
  • 5. Mental Health.
  • 6. Friends, Family, and Community.
  • 7. Intimacy and Sexuality.
  • 8. Work and Leisure.
  • 9. Finances and Lifestyles.
  • 10. Living Environments.
  • 11. The Oldest-Old and Caregiving.
  • 12. Special Problems.
  • 13. Women and Ethnic Groups.
  • 14. Death and Dying.
  • 15. Politics, Policies, and Programs.
  • Internet Information Resources.
  • References.
  • Photo Credits.
  • Name Index.
  • Subject Index.


Key Features
  • Expanded focus on current research with a greater emphasis on research methodology.
  • Multidisciplinary approach to the field of gerontology.
  • Each chapter begins with an "Old is News" article that draws attention to an older person in the news which underscores the human drama of aging and the unique aspect of aging on an individual basis.
  • "Thinking About Aging" features appear in most chapters and focus on important current issues.
  • "Fieldwork Suggestions" (at the end of each chapter) are designed to increase student interaction with senior citizens and to help the student apply the chapter material.


New to this edition
  • Throughout the text this edition has enhanced the global perspective.
  • All the "Old is News" boxes have been updated. These boxes are designed to jump-start student interest in each chapter with a news story to help students understand the practical reality of the chapter's concepts.
  • All the "Old is News" boxes have been updated. These boxes are designed to jump-start student interest in each chapter with a news story to help students understand the practical reality of the chapter's concepts.


About the Author
  • Susan Hillier is a former Coordinator of the Gerontology program at Sonoma State University. She holds a Ph.D in human development from the University of California, Davis.


Book Details

  • Paperback: 496 pages
  • Publisher: Wadsworth Publishing; 9 edition (March 11, 2011)
  • Language: English
  • ISBN-10: 0495811661
  • ISBN-13: 978-0495811664
  • Product Dimensions: 9.1 x 7.4 x 0.8 inches
List Price: $168.95 
 

Cavanaugh: Adult Development & Aging 6th Edition

Written within a biopsychosocial framework, Cavanaugh and Blanchard-Fields' best-selling text covers the specific ages-stages of adult development and aging. In its unparalleled coverage of current research and theory, the authors draw clear connections between research and application. The book's focus on "positive aging" and the gains and losses people experience across adulthood distinguish it from its competitors.


Contents 
  • 1. Studying Adult Development and Aging
  • 2. Neuroscience as a Basis for Adult Development and Aging
  • 3. Physical Changes
  • 4. Longevity, Health, and Functioning
  • 5. Where People Live: Person-Environment Interactions
  • 6. Attention and Memory
  • 7. Intelligence
  • 8. Social Cognition
  • 9. Personality
  • 10. Clinical Assessment, Mental Health, and Mental Disorders
  • 11. Relationships
  • 12. Work, Leisure, and Retirement
  • 13. Dying and Bereavement
  • 14. Successful Aging


Key Features
  • The book's scholarship is unparalleled. The authors are both well-known researchers and eminent academics who successfully integrate cutting-edge research in the text.
  • Reviewers and current users highly praise two distinctive chapters: Chapter 5, Where People Live: Person-Environment Interactions and Optimal Aging," and Chapter 8, "Social Cognition." (The chapter number and chapter title have been updated for the 6/e)--TT
  • The authors provide students with useful pedagogical tools for major sections within each chapter. Each section opens with Learning Objectives and ends with a Concept Check to help students determine the most important information from that section.
  • End-of-chapter pedagogy includes Review Questions organized by topic heading for quick review, Integrating Concepts in Development questions relating to other chapters, Key Terms (with definitions), and a comprehensive Resource list of annotated readings.
  • "How Do We Know?" boxes draw students' attention to specific research studies that are discussed briefly in the main body of the text. Details about the study's design, participants, and outcomes enable students to connect the information about these issues as presented in Chapter 1 ("Studying Adult Development and Aging") with the specific research that appears throughout the text.
  • "Current Controversies" boxes raise provocative issues about topics discussed in the chapter, helping students to think about the implications of research or policy issues.
  • "Discovering Development" boxes provide a starting point for applied projects by giving students a way to see developmental principles and concepts in the real world.


New to this edition
  • New discussions of global aging and the economics of aging.
  • New discussions of microgenetic research and the meta-analytic technique.
  • Revised discussions of osteoporosis, arthritis, theories of aging, and new information about dietary sodium and treatment for chronic obstructive pulmonary disease.
  • New How Do We Know? features in Chapters 3, 4, 10, 11, and 13.
  • New or revised Current Controversies features in Chapters 3, 5, 10, 11, 13, and 14.
  • New discussion of aging in place, home modification, congregate housing, assisted living, special care units, and the Green House concept of small home nursing homes.
  • New discussion on ecology of aging and community-based living options, including discussions of assisted living.
  • New discussion of gender differences in depression and mortality, and inclusion of a life-span view of alcohol abuse.
  • New Discovering Development features on caring for aging parents and on successful aging.
  • New subsection on making end-of-life intentions known.
  • New discussion of the four-component model of grief, and the dual process model of coping with grief.
  • New section on Social Security and Medicare.
  • New discussions on nutrition and exercise.


About the Author
  • John C. Cavanaugh, Ph.D., University of Notre Dame, is President of University of West Florida. He is a fellow of the American Psychological Association, The American Psychological Society and the Gerontological Society of America. He has been an American Council of Education Fellow and elected President of the Adult Development and Aging Division of the APA (Division 20). In addition, Dr. Cavanaugh was a Congressionally selected delegate to the 2005 White House Conference on Aging. His research interests in gerontology concern family care-giving as well as the role of beliefs in older adult's cognitive performance. He is also the co-author of ADULT DEVELOPMENT AND AGING, 5th Edition (Thomson Wadsworth, 2006) with Fredda Blanchard-Fields.
  • A new co-author, Fredda Blanchard-Fields, Professor of Psychology at Georgia Institute of Technology, joined John Cavanaugh in the 4th edition. Her research interests include social cognition in adulthood and aging, adaptive coping and everyday problem solving, and gender role development across the life span. She is responsible for the new separate chapter on Social Cognition, Chapter 9.


Book Details

  • Hardcover: 640 pages
  • Publisher: Wadsworth Publishing; 6 edition (January 1, 2011)
  • Language: English
  • ISBN-10: 0495601748
  • ISBN-13: 978-0495601746
  • Product Dimensions: 9.2 x 7.4 x 1.2 inches
List Price: $196.95 
 

Simmers: PPM (Practical Problems in Math) for Health Science Careers 3rd Edition

This book familiarizes students in Allied Health programs with essential math processes using real-life examples and straightforward instruction. Using a word problem format, this text starts with simple examples and progresses to complex paradigms to ensure students are engaged throughout each chapter. In addition to basic applications with whole numbers, fractions, and decimals, problems involving medications, intravenous solutions, and other emulsions information are also featured on common graphs, charts, and gauges. Thoroughly updated and expanded, Practical Problems In Mathematics For Health Science Careers, 3rd Edition provides a strong foundation in the essential math processes used in all areas of health care.


Contents
  • 1. Whole Numbers.
  • 2. Common Fractions.
  • 3. Decimal Fractions.
  • 4. Percent, Interest, and Averages.
  • 5. Ratio and Proportion.
  • 6. Metric and Other Measurements.
  • 7. Measurement Instruments.
  • 8. Graphs and Charts.
  • 9. Accounting and Business.
  • 10. Math for Medications.
  • 11. Introduction to Health Occupations.


Key Features
  • Specifically focused on practical math applications in the health care professions.
  • Outstanding graphics, charts, and diagrams help readers visualize the problems and learn how to interpret information.
  • Signature "Careers" chapter details the broad spectrum of employment opportunities in health care.
  • Familiarizes readers with the medical abbreviations used in math problems throughout the various health occupations.


New to this edition
  • Real drug labels are now used as figures to provide realistic math calculations.
  • New graphs and diagrams enhance the explanation of mathematical principles.
  • Additional problems that are updated to current day pricing and costs appear in every unit in the text.
  • Expanded coverage for Biotechnology Research and Development Careers that includes new review exercises.
  • Updated Careers chapter contains new educational requirements, salary ranges, and job-specific duties using National Healthcare Standards.


About the Author
  • Louise Simmers received a Bachelor of Science Degree in Nursing from the University of Maryland and a Masters degree in Education from Kent State University. She has worked as a public health nurse, a medical-surgical nurse, coronary care nurse and an instructor of Practical Nursing and Diversified Health Occupations. Louise has received the Vocational Educator of the Year award and the Diversified Health Occupations Instructor of the Year Award for the state of Ohio.
  • Karen Simmers-Nartker graduated from Kent State University, Ohio, with a Bachelor of Science Degree in Nursing. She has been employed as a telemetry step-down, medical intensive care, surgical intensive care, and neurological intensive care nurse. She is currently employed as a shift coordinator in an open-heart intensive care unit. She has obtained certification from the Emergency Nurses Association for the Trauma Nursing Core Course (TNCC) and from the American Heart Association for Advanced Cardiac Life Support (ACLS). In her current position as charge nurse in an ICU, she coordinates patient care and staff assignments; manages interpersonal conflicts among staff and/or patients and family members; is responsible for ensuring quality care to meet the diverse needs of patients and/or family; actively participates in inservices to evaluate new equipment, medications, hospital services and supplies; and teaches and mentors newly employed nurses.
  • Sharon Simmers-Kobelak graduated from Miami University, Ohio, with a Bachelor of Business Administration Degree. She is currently employed in the educational publishing industry as a Career Account Manager. In this position, she assists instructors at private career schools to find appropriate materials for classroom instruction. Sharon also provides inservice training for instructors on how to utilize the instructor and student resources in the most productive manner. She achieved President's Club status for two years and has repeatedly achieved quota with her publisher during her tenure with the company.


Product Details

  • Paperback: 368 pages
  • Publisher: Delmar Cengage Learning; 3 edition (March 7, 2012)
  • Language: English
  • ISBN-10: 1111540381
  • ISBN-13: 978-1111540388
  • Product Dimensions: 9.7 x 7.4 x 0.8 inches
List Price: $62.95 
 

Moini: Comprehensive Exam Review for the Pharmacy Technician 2nd Edition with CD-ROM

Comprehensive Exam Review for the Pharmacy Technician 2nd Edition is an essential book for your students as they prepare to take the Pharmacy Technician National Certification Exam. Essential material summaries provide a concentrated review of the topics covered on the National Certification Exam. Chapters are completely reorganized for improved mastery of information, with each chapter ending with a multiple-choice quiz to reinforce the review material. Chapters are structured to help your students assess their knowledge of the topic areas covered on the exam. Eight comprehensive self-examinations, each with 120 questions, are written in the certification exam style to provide a realistic test-taking experience. Answers for all of the quizzes and tests are included at the back of the book to facilitate self-directed study. To provide even more practice for your students, Comprehensive Exam Review for the Pharmacy Technician 2nd Edition includes a CD-ROM with an additional 600 multiple-choice questions, along with the option to create an unlimited number of comprehensive exams.



Contents 
SECTION I: INTRODUCTION AND GENERAL KNOWLEDGE.
  • 1. Pharmacy Technicians and Professional Organizations.
  • 2. Pharmacy Law and Ethics for Technicians.
  • 3. Pharmaceutical Terminology and Abbreviations.
  • 4. Structures and Functions of Body Systems.
  • 5. Common Disorders and Conditions.
  • 6. Dosage Forms and Routes of Administration.
  • 7. Pharmacy Calculations and Mathematics.
  • 8. Biopharmaceutics and Factors Affecting Drug Activity.
  • 9. Pharmacology Related to Various Body Systems.
SECTION II: ASSISTING THE PHARMACIST IN VARIOUS SETTINGS.
  • 10. Safety in the Workplace.
  • 11. Hospital Pharmacy.
  • 12. Community Pharmacy.
  • 13. Advanced Pharmacy.
  • 14. The Roles and Duties of Pharmacy Technicians.
  • 15. Sterile and Non-sterile Compounding.
SECTION III: ADMINISTRATION AND MANAGEMENT OF PHARMACY PRACTICE.
  • 16. Policies and Procedures.
  • 17. Management of Pharmacy Operations.
  • 18. Financial Management and Health Insurance.
  • 19. Computer Technology.
  • 20. Inventory Control.
Appendices
  • Appendix A: Pharmacy Technician Certification Examination.
  • Appendix B: State Boards of Pharmacy.
  • Appendix C: Professional Organizations.
  • Appendix D: Vitamins.
Self-Examinations:
  • Test I.
  • Test II.
  • Test III.
  • Test IV.
  • Test V.
  • Test VI.
  • Test VII.
  • Test VIII.
Glossary.
Answer Keys.
Index.


Key Features
  • The topics covered consist of essential material summaries highlighting key areas of pharmacology science, drug classifications, pharmaceutical calculation, and hospital and retail pharmacy.
  • Each chapter provides a multiple choice quiz, with answers at the back of the book, to allow for focused self-assessment of specific topics.
  • Includes a free CD-ROM that offers an additional six hundred multiple choice questions not found in the book.
  • Contains photos, illustrations, figures and tables throughout the book that reinforce important concepts for your students.


New to this edition
  • Reorganized into twenty chapters and consists of three sections, Introduction and General Knowledge, Assisting the Pharmacist in Various Settings, and Administration and Management of Pharmacy Practice.
  • Contains five Appendices: Pharmacy Technician Certification Exam, State Boards of Pharmacy, Professional Organizations, Top 200 Prescription Drugs, and Vitamins
  • Includes eight Self-Examinations, each containing one hundred twenty questions in the PTCB Exam format.
  • Contains new chapters that include Structures and Functions of Body Systems, Common Disorders and Conditions, and Sterile and Non-sterile Compounding.


About the Author
  • Jahangir Moini, M.D., M.P.H., C.Ph.T., is a professor of allied health programs at Everest University in Melbourne, Florida, where he established the medical assisting program in 1990 and the associate degree program for pharmacy technicians in 2000, as well as several other programs. He also served as director of allied health programs for 15 years and was director of the associate degree program for five years. In addition, Dr. Moini worked with the Brevard County Health Department as an epidemiologist and health educator consultant for 18 years, offering continuing education courses and updating nurses on new developments related to pharmacology, medication errors, immunizations, and other important topics. Today, he is actively involved in teaching and preparing students for service in various health professions, including roles as pharmacy technicians, medical assistants, and nurses. Since 1990, Dr. Moini has published many allied health books internationally. He holds a medical degree (M.D.) and a master's degree in public health (M.P.H.) and is a certified pharmacy technician (C.Ph.T.).


Product Details

  • Paperback: 416 pages
  • Publisher: Delmar Cengage Learning; 2 edition (January 1, 2011)
  • Language: English
  • ISBN-10: 1111128472
  • ISBN-13: 978-1111128470
  • Product Dimensions: 10.8 x 8.4 x 0.7 inches
List Price: $72.95 
 

Dressman: Oral Drug Absorption: Prediction & Assessment 2nd Edition with DVD

Ten years ago, the first edition of Oral Drug Absorption was published with the intent of closing the gap between gastroenterology textbooks on the physiology of the gastrointestinal (GI) tract and pharmaceutical textbooks on oral drug formulations. In the ensuing years, the field of oral drug absorption has evolved significantly on several fronts. First, there has been acceptance and increasing implementation of the biopharmaceutics classification scheme (BCS) concept, both at the regulatory and drug development levels. Second, application of biorelevant media to better understand active pharmaceutical ingredient (API) behavior in the GI tract has become widespread, not only for solubility and dissolution, but also for permeability applications. Third, the role of transporters in drug uptake across the GI mucosa has been recognized and is under intensive investigation. The same applies to drug metabolism in the gut wall, and within the next decade, we should be able to quantitatively describe both of these phenomena as they relate to prediction of API bioavailability. Fourth, our understanding of GI hydrodynamics and the availability of fluid in the various segments of the GI tract is slowly but surely improving. Fifth, there is a very strong interest in applying physiologically based pharmacokinetic (PBPK) modeling to oral drug absorption; this has become possible with the advent of sophisticated software programs like GastroPlus1 and PK-Sim1 and will surely become one of our most powerful tools in the years to come. And last but not least, the quality by design paradigm has aroused interest in new techniques to better link the composition and manufacture of oral drug products with their in vivo performance.

As a result of all these developments, it is high time to bring out a second edition of Oral Drug Absorption that captures the rapid progress in the field. In this edition, we start out with a chapter on the fundamentals of GI physiology— as it relates to oral drug absorption—and in the first section, we describe several aspects in more detail in chapters specifically addressing absorption mechanisms, GI motility, gut wall metabolism, food effects, and drug absorption in children and various disease states. The second section focuses on the BCS and the impact it is making on pharmaceutical R&D and regulation of oral drug products. Additionally, separate chapters are devoted to the measurement and interpretation of the key BCS parameters, solubility and permeability. The third section, entitled ‘‘Nonclinical Methods to Evaluate Oral Formulations,’’ first describes appropriate dissolution tests to characterize formulations in preclinical development—be they intended for immediate or controlled release in the GI tract. Then state of the art practice for formulation screening and development in the industry is recounted for immediate release products and for controlled release products. This section is wrapped up by a chapter devoted to implementation of PBPK modeling at the preclinical level. The last section turns attention to bioequivalence studies. Increasingly, alternatives to human pharmacokinetic studies are being used to obtain approval of generic drug products and to obtain continued approval for existing products when changes have been made to the composition or method of manufacture. The section is introduced with a chapter providing the fundamentals and current status of bioavailability and bioequivalence. The application of BCS and in vitro–in vivo correlation (IVIVC) to the proof of bioequivalence is then described in separate chapters, and the evolution of regulations pertaining to bioequivalence is put into global perspective. In recognition of the increased interest in application of IVIVC for proof of bioequivalence, we have also provided a CD, which shows the user how to generate IVIVCs utilizing an Excel spreadsheet. Numerous examples are given to illustrate the underlying theory and show how the IVIVC works, and it is hoped that this CD will become an integral part of the toolbox used by pharmaceutical scientists to facilitate formulation design and optimization on a day-to-day basis.

Of course, producing a new edition of a textbook requires the assistance of many people, and Oral Drug Absorption is no exception. We wish to thank Sandy Beberman and Sherri Niziolek for their untiring enthusiasm and support of this project. We are also indebted to the authors for their splendid efforts in preparing chapters that reflect state-of-the-art thinking in oral drug absorption. We also wish to thank our families for their support and understanding that books are largely created in the evenings and on weekends. Finally, we thank the readers of the first edition for the excellent feedback and stimulus to produce an updated version.
- The Editors -


Contents
Part I: Physiology of Oral Drug Absorption
  • 1. Physiological Factors Affecting Drug Release and Absorption in the Gastrointestinal Tract
  • 2. Drug Transport Mechanisms Across the Intestinal Epithelium
  • 3. Gastrointestinal Transit and Drug Absorption
  • 4. Gut Wall Metabolism
  • 5. Food Effects on Drug Absorption and Dosage Form Performance
  • 6. Oral Drug Absorption in Pediatric Populations
  • 7. Gastrointestinal Disease and Dosage Form Performance

Part II: The Biopharmaceutics Classification System
  • 8. The Biopharmaceutics Classification System: Recent Applications in Pharmaceutical Discovery, Development, and Regulation
  • 9. Drug Solubility in the Gastrointestinal Tract
  • 10. Permeability Measurement
  • 11. BCS: Today and Tomorrow

Part III: Nonclinical Methods to Evaluate Oral Formulations
  • 12. Dissolution Testing to Forecast In Vivo Performance of Immediate-Release Formulations
  • 13. Dissolution Testing to Forecast the In Vivo Performance of MR Formulations
  • 14. Modified-Release Dosage Forms: Formulation Screening in the Pharmaceutical Industry
  • 15. Immediate Release Oral Dosage Forms: Formulation Screening in the Pharmaceutical Industry
  • 16. Computer Models for Predicting Drug Absorption

Part IV: Bioequivalence Studies
  • 17. In Vivo Bioequivalence Assessment
  • 18. Biowaiving Based on the BCS—A Global Comparison
  • 19. Biowaiving Based on In Vitro-In Vivo Correlation
Appendix
Index


Product Details

  • Hardcover: 450 pages
  • Publisher: Informa Healthcare; 2 edition (January 15, 2010)
  • Language: English
  • ISBN-10: 1420077333
  • ISBN-13: 978-1420077339
  • Product Dimensions: 9 x 6.2 x 1.1 inches
List Price: $229.95 

Kroner: Vitamins and Minerals

Many patients and holistic practitioners take it upon themselves to take and prescribe, respectively, a unique concoction of supplements, disregarding all side effects and negative research. Their approach is such that supplements can do no harm and that medications are not a cure-all. This premise is of course skewed as well.

In this book, I will bring to light many of the common supplements, as they may play a significant role in helping to improve a variety of medical illnesses. I will discuss the supplements’ mechanisms of action, the research behind them, and their evidence-based risks and benefits that you have to be aware of. Simply knowing this information allows you to be more involved with your own medical care. This book is not an endorsement of supplements, but a way for you to find out the fact versus the fiction behind the popularly used supplements.

It must be brought to your attention that every single study included in this book is from prominent medical journals that your physician is expected to read on a regular basis. The excuse that there is not enough evidence in the medical literature to actually recommend certain supplements on a regular basis is wrong and is a reflection of physicians not reading the journals that are put out by the very organizations that they belong to.

We should all expect a lot from our physicians. Physicians are there for you, not instead of you. My view of a physician is one who is sincere and has a close relationship with his or her patients; one who always practices a cause-oriented approach for every medical sign and symptom; one who is not quick to give a medication or neutraceutical to cover up a problem; one who discusses a variety of medical options, both medicinal and natural alike, addressing the risks and benefits of both; and one who always uses evidence-based medicine while staying abreast of the most current and pertinent medical literature.

Unfortunately, the state of medicine today makes the physician and patient feel rushed during an office visit. Most of the 10–15 minutes of time allotted to your physician to spend with you is spent on relatively urgent medical issues, checklist preventive medicine, and of course paperwork.

Please understand, the goal of this book is definitely not to put you on a slew of supplements. It is to show you the pros and the cons of many of the commonly prescribed neutraceuticals, so that you can be knowledgeable about the decision that you and your physician make. The physician should be your vehicle for recovery, but remember that you, and only you, are the driver.
- The Authors -


Contents
  • Introduction
  • 1. 5-Hydroxy-Tryptophan (5-HTP)
  • 2. Alpha Lipoic Acid
  • 3. Beta-Sitosterol
  • 4. Biotin
  • 5. Calcium
  • 6. Chromium
  • 7. Coenzyme Q10 (CoQ10)
  • 8. Copper
  • 9. Creatine
  • 10. D-Ribose
  • 11. Folic Acid
  • 12. Glucosamine
  • 13. Glutathione (GSH)
  • 14. L-Carnitine
  • 15. L-Arginine
  • 16. Vitamin C
  • 17. Iodine
  • 18. Iron
  • 19. L-Glutamine
  • 20. L-Lysine
  • 21. L-Tyrosine
  • 22. Melatonin
  • 23. MSM
  • 24. N-Acetylcysteine
  • 25. Niacin (Vitamin B3)
  • 26. Omega-3 Fatty Acids
  • 27. Saccharomyces Boulardii
  • 28. S-Adenosylmethionine (SAMe)
  • 29. Selenium
  • 30. Vitamin A
  • 31. Vitamin B12
  • 32. Vitamin D
  • 33. Vitamin E
  • 34. Vitamin K
  • 35. Zinc
  • 36. Magnesium
  • 37. Vanadyl Sulfate
  • 38. Probiotics
  • 39. Strontium Ranelate
  • Index


Product Details

  • Hardcover: 383 pages
  • Publisher: Greenwood (April 8, 2011)
  • Language: English
  • ISBN-10: 0313382247
  • ISBN-13: 978-0313382246
  • Product Dimensions: 10 x 7.3 x 1.2 inches
List Price: $85.00 
 

Correa: Getting Started in the Computerized Medical Office: Fundamentals & Practice 2nd Edition Includes MOSS 2.0

Getting Started in the Computerized Medical Office: Fundamentals and Practice 2nd Edition and the accompanying Medical Office Simulation Software 2.0 (MOSS 2.0) will help prepare your students to work with any practice management software used in medical offices today. The book follows the flow of information as patients are scheduled and seen in a medical office, through procedure posting, billing and collections. Content within the book is grouped by subject for easy reading, followed by immediate application of the concepts to the software.


Contents 
  • Preface.
  • 1. Introduction to Computers.
  • 2. Medical Practice-Management Software.
  • 3. Basic Management Concepts for Medical Administrative Staff.
  • 4. Fundamentals of Medical Insurance.
  • 5. Patient Registration and Data Entry.
  • 6. Procedure Posting Routines.
  • 7. Insurance Billing Routines.
  • 8. Posting Payments and Secondary Insurance Billing.
  • 9. Patient Billing and Collections.
  • 10. Posting Secondary Insurance Payment and Electronic Remittance Advice Payments.
  • 11. Insurance Claim Follow-Up and Dispute Resolution.
  • Source Document Appendix.
  • Glossary.
  • Index.


Key Features
  • Numerous screen shots help users check their work and complete each activity with confidence.
  • Objectives at the beginning of each unit clearly specify the content to be learned and the skills that will be mastered using the software, where applicable. Each exercise has its own objective, giving the instructor and the learner direction on the purpose or desired outcome upon completion of the task.
  • Exercises include step-by-step directions supported by many screen shots, showing how the screen should look before and after processing data, where applicable.
  • Each unit ends with the Final Notes section, summarizing the material just learned, and relating it to the topic forthcoming in the next unit.
  • Each unit provides a Check Your Knowledge review section to reinforce the topics learned.
  • Together, the book and software provide approximately 30 hours of activity.


New to this edition
  • New Workbook with additional hands-on activities to reinforce and expand knowledge presented in the textbook.
  • New Instructor Resources CD-ROM with instructor slides in Microsoft PowerPoint and electronic Instructor's Manual.
  • All exercises updated to correspond with MOSS 2.0 new features, functionality, buttons, and dates.
  • Source documents now provided in an appendix to allow for easier viewing and utilization with the exercises.
  • Key terms identified at the beginning of each chapter.
  • MOSS 2.0 Notes feature identifies usability and troubleshooting tips while working with the software.


About the Author
  • Cindy Correa has spent the majority of her time teaching in technical schools and colleges that offer medical career programs. Most recently, she was the Allied Health Educational Coordinator and senior instructor at City University of New York at Queens College. Cindy was responsible for the initial creation and curricula development of at least seven certificate programs of the Allied Health Program and extended her expertise to satellite courses in outlying adult education programs. Her experience and understanding of the dynamics and challenges of teaching in technical schools, including computer lab courses, has helped create a book that facilitates instructors and students. Her experience working in the private practice and administrative hospital environments includes oncology, cardiovascular surgery, pulmonology, and thoracic surgery.


Product Details

  • Spiral-bound: 699 pages
  • Publisher: Delmar Cengage Learning; 2 edition (August 17, 2011)
  • Language: English
  • ISBN-10: 1435438477
  • ISBN-13: 978-1435438477
  • Product Dimensions: 11 x 8.8 x 1.1 inches
List Price: $116.95 
 

Bleavins: Biomarkers in Drug Development: A Handbook of Practice, Application & Strategy

In recent years, the topic of biomarkers has been featured at many specialized scientific meetings and has received extensive media coverage. We, the coeditors, felt that a book that approached the topic with an emphasis on the practical aspects of biomarker identification and use, as well as their strategic implementation, was missing and essential to improve the application of these approaches. We each have experience working with biomarkers in drug development, but we recognized that the specialized knowledge of a diverse group of experts was necessary to create the type of comprehensive book that is needed. Therefore, contributions were invited from authors who are renowned experts in their respective fields. The contributors include scientists from academia, research hospitals, biotechnology and pharmaceutical companies, contract research organizations and consulting firms, and the FDA. The result is a book that we believe will appeal broadly to pharmaceutical research scientists, clinical and academic investigators, regulatory scientists, managers, students, and all other professionals engaged in drug development who are interested in furthering their knowledge of biomarkers.

As discussed in Part I, biomarkers are not new: They have been used for hundreds of years to help physicians diagnose and treat disease. What is new is a shift from outcome biomarkers to target and mechanistic biomarkers, the availability of “ omics, ” imaging, and other technologies that allow collection of large amounts of data at the molecular, tissue, and whole - organism levels, and the use of data - rich biomarker information for “ translational research, ” from the laboratory bench to the clinic and back. Part II chapter is dedicated to highlighting several important technologies that affect drug discovery and development, the conduct of clinical trials, and the treatment of patients.

In Part III we ’ ve invited leaders from industry and regulatory agencies to discuss the qualification of biomarker assays in the fit - for - purpose process, including perspectives on the development of diagnostics. The importance of statistics cannot be overlooked, and this topic is also profiled in this part with a practical overview of concepts, common mistakes, and helpful tips to ensure credible biomarkers that can address their intended uses. Parts IV to VI present information on concepts and examples of utilizing biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Examples are drawn from a wide range of target - organ toxicities, therapeutic areas, and product types. We hope that by presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work.

Part VII focuses on “ lessons learned ” and the practical aspects of implementing biomarkers in drug development programs. Many pharmaceutical companies have created translational research divisions, and increasingly, external partners, including academic and government institutions, contract research organizations, and specialty laboratories, are providing technologies and services to support biomarker programs. This is changing the traditional organizational models within industry and paving the way toward greater collaboration across sectors and even among companies within a competitive industry. Perspectives from contributing authors representing several of these different sectors are presented in this part, as well as a legal perspective on potential intellectual property issues in biomarker development. The book concludes with Part VIII on future trends and developments, including developments in data integration, the reality of personalized medicine, and the addressing of ethical concerns. The field of biomarkers in drug development is evolving rapidly and this book presents a snapshot of some exciting new approaches. By utilizing the book as a source of new knowledge, or to reinforce or integrate existing knowledge, we hope that readers will benefit from a greater understanding and appreciation of the strategy and application of biomarkers in drug development and become more effective decision makers and contributors in their own organizations. 


Contents
PART I BIOMARKERS AND THEIR ROLES IN DRUG DEVELOPMENT
  • 1 Biomarkers Are Not New
  • 2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care
  • 3 Enabling Go/No Go Decisions

PART II IDENTIFYING NEW BIOMARKERS: TECHNOLOGY APPROACHES
  • 4 Imaging as a Localized Biomarker: Opportunities and Challenges
  • 5 Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics
  • 6 Quantitative Multiplexed Patterning of Immune-Related Biomarkers
  • 7 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity
  • 8 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules

PART III CHARACTERIZATION AND VALIDATION
  • 9 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective
  • 10 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development
  • 11 Molecular Biomarkers from a Diagnostic Perspective
  • 12 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation
  • 13 Importance of Statistics in the Qualification and Application of Biomarkers

PART IV BIOMARKERS IN DISCOVERY AND PRECLINICAL SAFETY
  • 14 Qualification of Safety Biomarkers for Application to Early Drug Development
  • 15 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor
  • 16 Biomarkers for the Immunogenicity of Therapeutic Proteins and its Clinical Consequences
  • 17 New Markers of Kidney Injury

PART V TRANSLATING FROM PRECLINICAL RESULTS TO CLINICAL AND BACK.
  • 18 Translational Medicine-A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers
  • 19 Clinical Validation and Biomarker Translation
  • 20 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis
  • 21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations
  • 22. Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints

PART VI BIOMARKERS IN CLINICAL TRIALS.
  • 23 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development
  • 24 Integrating Molecular Testing into Clinical Applications
  • 25 Biomarkers for Lysosomal Storage Disorders
  • 26 The Value Chain in the Development of Biomarkers for Disease Targets

PART VII LESSONS LEARNED: PRACTICAL ASPECTS OF BIOMARKER IMPLEMENTATION.
  • 27 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork
  • 28 Integrating Academic Laboratories Into Pharmaceutical Development
  • 29 Funding Biomarker Research and Development Through the Small Business Innovative Research Program
  • 30 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices
  • 31 Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to be Rare or Hard to Find
  • 32 Biomarker Patent Strategies: Opportunities and Risks

PART VIII WHERE ARE WE HEADING AND WHAT DO WE REALLY NEED?
  • 33 IT Supporting Biomarker-Enabling Drug Development
  • 34 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine
  • 35 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection
  • 36 Pathodynamics: Improving Biomarker Selection By Getting More Information From Changes Over Time
  • 37 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective
  • 38 Nanotechnology-Based Biomarker Detection
Index.


About the Authors
  • MICHAEL R. BLEAVINS, PhD, is cofounder of Michigan Technology and Research Institute. He retired from Pfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-three years of experience in pharmaceutical research, development, and biomarkers with more than sixty-five peer-reviewed publications.
  • CLAUDIO CARINI, MD, PhD, FRCPath, is Chief Medical Officer and Vice President for Clinical Research at Fresenius. Previously, Claudio served as Global Head of Translational Medicine at MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudio has more than twenty years of experience in the field of immunology and biomarkers and has authored more than 200 publications in international and domestic peer-reviewed journals.
  • MALLÉ JURIMA-ROMET, PhD, is Senior Director for Development and Regulatory Services at MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. MallĂ© has authored over forty peer-reviewed publications and is an adjunct professor at the University of Montreal.
  • RAMIN RAHBARI, MS, is cofounder and Senior Consultant at Innovative Scientific Management. Previously, Ramin has held positions at Pfizer, Synaptic, and Parke-Davis pharmaceutical companies, leading cross-functional biomarker teams.

 
Product Details

  • Hardcover: 800 pages
  • Publisher: Wiley; 1 edition (February 15, 2010)
  • Language: English
  • ISBN-10: 0470169273
  • ISBN-13: 978-0470169278
  • Product Dimensions: 6.5 x 1.6 x 9.2 inches
List Price: $169.00 
 

Greene: Pathology & Therapeutics for Pharmacists 3rd Edition: A basis for clinical pharmacy practice

The response to the previous editions of this text have been favourable, and it has clearly fulfilled a need of target audience. Since the last edition the important changes that have transformed pharmacotherapy are the rise of evidence based medicine (EBM) and the firm establishment of national and international therapeutic guidelines, usually based on careful meta-analyses of randomized controlled trials. These have frequently been issued by disease specific organizations such as the British Hypertension Society, or generic bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Prescribing Centre in the UK.

These guidelines have been incorporated into this edition wherever available, and have been a main focus of the update. However, as before, the overall intention remains to demonstrate how knowledge of the biomedical sciences of physiology, pathology and pharmacology underpins understanding of the rationale behind these recommendations.

The new edition will be as useful as the first two evidently have, and that it will continue to interest practitioners of disciplines outside the confines of pharmacy, reflecting the multidisciplinary nature of modern healthcare.


New to this edition 
  • significantly reorganized and harmonized the sections and headings to improve consistency in structure and comprehension. These changes, together with a more detailed index, have enabled us to use an improved internal cross-referencing system.
  • Where there are crossreferences within a chapter, the reader is directed to a closely-associated block of text or, if the reference is more remote, the page number is given.
  • Cross-references outside a chapter give the chapter number, which together with the index should enable the material to be located quickly.
  • Coverage of Thyroid disease in the Endocrine chapter have been added.
  • A new chapter on Haematological disease.
  • The use of drugs in renal impairment has been expanded in the Renal chapter.
  • Evidence based therapeutic guidelines have been emphasized throughout.
  • The References and further reading lists have been updated and rINNs are used throughout for drug nomenclature, following the BNF wherever possible.


Contents
  • Dedication and acknowledgements
  • with a note on drug nomenclature
  • Preface to the third edition
  • Extract from preface to the first edition
  • About the authors
  • Recommended reference sources
  • Abbreviations
  • Plate section between pages 854 and
PART 1 Basic strategy and introduction to pathology
1 Therapeutics: general strategy
  • Terminology of disease
  • Case history
  • Drug disposition
  • Drug selection
  • References and further reading
2 Major pathological processes in disease
  • Introduction
  • Immunology
  • Inflammation
  • Ischaemia

PART 2 Body systems and their principal diseases
  • 3 Gastrointestinal and liver diseases
  • 4 Cardiovascular system
  • 5 Respiratory diseases
  • 6 Central nervous system
  • 7 Pain and its treatment
  • 8 Infections and antimicrobial therapy
  • 9 Endocrine system
  • 10 Neoplastic disease
  • 11 Haematology
  • 12 Rheumatology: musculoskeletal and connective tissue diseases
  • 13 Skin diseases
  • 14 Renal system
Index


About the Editors
Russell J. Greene, BPharm MSc PhD MRPharmS, Senior Lecturer in Clinical Pharmacy, Former Head, Pharmacy Practice Group, Department of Pharmacy, King’s College London, University of London, UK.
Dr Russell Greene gained his BPharm from Nottingham University in 1967 and did his pre-reg in Elizabeth Garrett Anderson hospital in London.
After working in hospital and community pharmacy in the UK and abroad he gained an MSc by research from Bath University in 1973 for a thesis on Drug administration in psychiatric hospitals.
Following a further spell abroad, including a year setting up a pharmacy training course at the University of the South Pacific in Fiji, in 1978 he became the Principal pharmacist for Education and training for the NWThames Regional Health Authority.
He joined Chelsea College in 1980 to teach clinical pharmacy and moved with it to King’s College in 1987. He gained his PhD in 1993 for a thesis on Prescription monitoring by community pharmacists and the role of medication records. He became senior lecturer in 1995 and
head of the Pharmacy Practice group in 1998. He was the MPharm Programme director until 2006, and his principal teaching responsibility has been organizing courses in pathology and therapeutics.

Norman D. Harris, BPharm PhD DIC, Emeritus Reader in Pharmaceutics, Department of Pharmacy, King’s College London, University of London, UK.
Dr Norman Harris entered Pharmacy in 1947 following National Service, having been an industrial chemist in metal processing and the food industry.
As apprentice at a very traditional London pharmacy, which dispensed for nearby embassies, he learned full-range extemporaneous dispensing, including suppositories, pessaries and silvered pills from prescriptions written in 1910!
At Chelsea School of Pharmacy he acquired the Chemist and Druggist and Pharmaceutical Chemist Diplomas, a BPharm degree, and won the Pharmaceutical Society’s Pereira Medal. A spell at Imperial College led to a PhD in Microbiology and the Imperial College Diploma and Fellowship of the Pharmaceutical Society followed in 1954.
On the staff at Chelsea, he taught Pharmacognosy (briefly), Pharmaceutics (Dispensing, Microbiology, Radiopharmacy), becoming Reader in Pharmaceutics and Head of Clinical Pharmacy, Honorary Pharmacist at Hammersmith Hospital and Chairman of the Oxford Region Pharmacy Advisory Committee. He was Post-graduate Tutor for the North-West Thames Region for many years and retired in 1984.


Product Details

  • Paperback: 982 pages
  • Publisher: Pharmaceutical Press; 3 edition (February 28, 2008)
  • Language: English
  • ISBN-10: 085369690X
  • ISBN-13: 978-0853696902
  • Product Dimensions: 9.7 x 7.5 x 2 inches
List Price: $82.50 
 

Nathan: Non-Prescription Medicines 4th Edition

In this book, OTC (over the counter) medicines currently available in the UK are reviewed in alphabetically arranged chapters on the conditions for which they are licensed to treat. This book will also be of value to pharmacists and other health professionals in the Republic of Ireland, because most of the proprietary branded medicines available in the UK are also available under the same name in Ireland. Also, patients from the UK, including from Northern Ireland, often ask for UK products, and these products are familiar as transnational advertising raises awareness. The classification of non-prescription medicines in Ireland is generally similar to that it in the UK, but due to licensing restrictions some medicines that are available without prescription in the UK are not in Ireland.

Information is provided on the following aspects of products:
  • compounds or constituents,
  • mode of action,
  • indications,
  • evidence of efficacy,
  • side-effects,
  • cautions and contraindications,
  • interactions,
  • dosage,
  • presentations and formulations,
  • products available and manufacturers (either all products in a category or, for categories where there are a large number of products, a representative selection),
  • each section concludes with a summary of key points and suggestions for the most appropriate products to recommend.

Evidence of the efficacy of medicines is cited where it exists. However, few clinical trials on medicines for OTC use have been published, and most of the available evidence comes from the use of medicines as POMs before their reclassification to P status. In some instances, medicines are licensed for nonprescription use for different indications and at different doses from their use as prescription drugs, and caution may therefore be necessary in extrapolating clinical trial evidence to OTC use. There is very little clinical trial evidence for medicines that were already licensed for OTC use before POM-to-P reclassifications began. Such trials as could be found and appear to meet current methodological standards are cited.

This edition has been completely revised and brought up to date. New products have been included and assessed, and discontinued products have been deleted. New chapters on chlamydia obesity, and benign prostatic hyperplasia have been added.

A feature introduced with the last edition - the publication of 6-monthly updates on the Pharmaceutical Press website (www.pharmpress.com/onlineresources) - is continued with this edition.
- The Author -


Contents 
  • 1 Acne
  • 2 Athlete's foot
  • 3 Benign prostatic hyperplasia
  • 4 Cardiovascular medicines
  • 5 Chlamydia (Chlamydia trachomatis infection)
  • 6 Colds
  • 7 Cold sores
  • 8 Constipation
  • 9 Corns and calluses
  • 10 Cough
  • 11 Cradle cap
  • 12 Cystitis
  • 13 Dandruff and seborrhoeic dermatitis
  • 14 Diarrhoea
  • 15 Dry skin
  • 16 Ear problems
  • 17 Emergency hormonal contraception
  • 18 Eye conditions
  • 19 Fungal nail infection (onychomycosis)
  • 20 Haemorrhoids
  • 21 Hay fever
  • 22 Head lice
  • 23 Indigestion
  • 24 Insect bites and stings
  • 25 Irritable bowel syndrome
  • 26 Irritant and allergic dermatitis and mild eczema
  • 27 Migraine
  • 28 Motion sickness
  • 29 Mouth ulcers
  • 30 Nappy rash
  • 31 Obesity management
  • 32 Oral thrush
  • 33 Pain
  • 34 Pattern baldness
  • 35 Premenstrual syndrome
  • 36 Scabies
  • 37 Smoking cessation products
  • 38 Sore throat
  • 39 Temporary sleep disturbance
  • 40 Threadworm and roundworm
  • 41 Vaginal candidiasis
  • 42 Vaginitis and vaginal dryness
  • 43 Verrucas
  • 44 Warts
  • Index


About the author
Alan Nathan has extensive experience of both community and academic pharmacy. He has been a locum, employee and proprietor community pharmacist, and for 15 years he was a lecturer in pharmacy practice at the Department of Pharmacy, King’s College London University. Since 2004, Alan has been a freelance pharmacy writer, publishing widely in pharmacy and other health profession journals and the consumer press. He has authored two books: this one and Fast Track: Managing symptoms in the pharmacy (Pharmaceutical Press, 2008). His main areas of writing interest are the management of minor ailments, and pharmacy law and ethics and professionalism. Alan has also been a consultant to several pharmacy organisations and companies. Alan was a member of the Council of the Royal Pharmaceutical Society from 1986 until 2002, and is co-founder and chairman of the Pharmacist Support Listening Friends stress help scheme for pharmacists.


Product Details

  • Paperback: 308 pages
  • Publisher: Pharmaceutical Press; 4 edition (June 2010)
  • Language: English
  • ISBN-10: 0853698864
  • ISBN-13: 978-0853698869
  • Product Dimensions: 9.1 x 6.1 x 0.8 inches
List Price: $55.00 
 

Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and the practice of medicine and regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology and combination product fields) in a concise, abbreviated manner for all the major world market countries.

As when teaching on the subject of drug safety evaluation, the approach I have taken here is to first address the broadest scope "general case" for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parenteral, dermal, and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences.

As will be seen, even for ICH countries there is (in mid-2009) continuing modification of the basic M3 guidance for small molecule drugs (R2 being released in step 2 in August of 2008) and S6 (for protein therapeutics) series guidances, and it is not expected that the situation captured and guidance offered in this volume will long withstand the need for regular updating. The drivers for such need will be new science, new ways of using therapeutic products, new concerns, and the influence of new major markets. Also, there will be new real or perceived drug safety concerns. Much of these effects translate to "regulatory creep" (unpublished changes in practice and expectations by different parts of regulatory agencies that proceed in an undocumented fashion almost from the moment a new regulatory guidance comes out), and tracking these changes in a published text approaches is a hopeless task.

It is also not intended that this volume addresses the specifics of study design and interpretation. There are several current texts which perform these tasks well (Gad and McCord, 2008 for devices, Gad 2009 for drugs, and Cavanaro 2008 specifically for biotechnology products) and in the details required. Adequate references are provided to guide the reader (user) of this volume directly to the details required.
- The Author -


Contents 
Introduction to Safety Assessment in Drug and Medical
  • Device Development
  • Global Pharmaceutical and Medical Device Markets
  • Legislative Considerations
  • Regulations: Human Pharmaceuticals
  • Special Cases: Biologics and Combination Products
  • Strategies for Development Drugs
  • What You Need to Know to Start
  • Devices
  • References

Drugs: The General Case
  • IND/FIM Enabling
  • To Support Continued Clinical Development
  • To Support Marketing Approval
  • Subset: Special or Hazard Studies
  • ICH Requirements: The Global General Case
  • The First Rule
  • References

IND-Enabling Toxicology Programs
  • Toxicity Testing: Traditional Pharmaceuticals
  • Common Mistakes
  • Toxicity Testing of Pharmaceuticals: The General Approach
  • Developmental and Reproductive Toxicity Studies
  • Genetic Toxicity Assessment
  • Safety Pharmacology Studies
  • Toxicity Testing: Biotechnology Products
  • Toxicology Testing: Special Cases
  • Oral Contraceptives
  • Life-Threatening Diseases (Compassionate Use)
  • Antibiotics and Anti-Infectives
  • Special Cases
  • Direct to FIM Trials: Imaging Agents
  • Gene Therapy
  • Cellular (Stem Cell) Therapy
  • Excipients
  • Pediatric Claims and Juvenile Animal Studies
  • Exploratory INDs
  • References

Nonclinical Safety Evaluation Studies Conducted to Support
  • Continued Clinical Development
  • Repeat Dose Toxicity
  • Developmental and Reproductive Toxicology (DART)
  • Impurities, Degradants, and Residual Solvents
  • Impurities
  • Residual Solvents
  • Extractables and Leachables
  • Residual Metals and Metal Catalysts
  • Safety Assessment of Metabolites (Metabolites in Safety Testing – MIST)
  • Local Tissue Tolerance
  • Nonclinical Abuse Liability
  • Drug Registration in Japan
  • Drugs in China; Pharmacology and Toxicology Study Information
  • References

Supporting Marketing Applications
  • Non-Traditional (Other than NDA/505b (1)) Approval Routes and Requirements
  • Carcinogenicity
  • Pre- and Post-natal Development
  • Pediatric Population Studies
  • Special Cases
  • References

Special Therapeutic Category and Route of Administration Cases
  • Specific Therapeutic Classes
  • Oncology Drugs
  • Activity Profile and Mechanism of Action
  • Mechanism(s) of Resistance
  • Special Considerations for Biopharmaceutical Studies
  • Nonclinical Data Evaluation to Support Clinical Trial Design
  • Start Dose for First Administration in Human
  • Dose Escalation and the Highest Dose in a Clinical Trial
  • Duration and Schedule of Toxicology Studies to Support
  • Initial Clinical Trials
  • Duration of Toxicology Studies to Support Continued Development
  • Combinations of Pharmaceuticals
  • Studies in Pediatric Populations
  • Special Considerations for Biologics
  • Conjugated Agents
  • Liposomal Formulated Products
  • Evaluation of Drug Metabolites
  • Evaluation of Impurities
  • Other Life-Threatening Chronic Diseases
  • Imaging Agents
  • Antibiotics
  • Vaccines
  • Routes and Regimens Other than Oral and Daily
  • Combination Products
  • Historical Background
  • References

Device Safety Evaluation
  • Introduction
  • Regulatory Definition of Medical Devices
  • International Standards Organization
  • Topical Devices
  • Blood Path Direct
  • Japan
  • Other Regulatory Guidances
  • Biological Tests
  • References
About the Author
Appendix A Notable Regulatory Internet Addresses
Index


About the Author
Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, a 17-year-old consulting firm with 6 employees and more than 450 clients (including 120 pharmaceutical companies in the USA and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen, and Becton Dickinson. He has published 39 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and safety assessment. He has more than 33 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment.
He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (90 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA, and NIH, and has trained reviewers and has been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 22 years.


Product Details

  • Hardcover: 140 pages
  • Publisher: Springer; 1st Edition (2011)
  • Language: English
  • ISBN-10: 1441974482
  • ISBN-13: 978-1441974488
  • Product Dimensions: 9.2 x 6.1 x 0.5 inches
List Price: $139.00 
 
 

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