Principles and Practice of Pharmaceutical Medicine E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 2120

Veröffentlichungsjahr: 2011

Beschreibung

The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.

Leseprobe

Contents

Contributors

Preface to the First Edition

Preface to the Second Edition

Preface to the Third Edition

About the Editors

SECTION I OVERVIEW OF PHARMACEUTICAL MEDICINE

CHAPTER 1: THE PRACTICE AND PRACTITIONERS OF PHARMACEUTICAL MEDICINE

ANTHONY W. FOX

THE DIVERSITY OF PHARMACEUTICAL MEDICINE

THE DIVERSITY OF THE PRACTITIONERS

ORGANIZATIONS AND EDUCATIONAL SYSTEMS

CHAPTER 2: PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY

MICHAEL D. YOUNG & PETER D. STONIER

EDUCATION AND TRAINING IN PHARMACEUTICAL MEDICINE

CONTINUING PROFESSIONAL DEVELOPMENT

EDUCATION AND TRAINING PROGRAMS IN PHARMACEUTICAL MEDICINE

REFERENCES

CHAPTER 3: CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF

PETER MARKS & SHEILA GWIZDAK

INTRODUCTION

WHAT IS A COMPETENCY-BASED TRAINING PROGRAM?

COMPETENCY-BASED TRAINING PROGRAM FOR STAFF ASSOCIATED WITH CONDUCTING CLINICAL TRIALS

REFERENCES

SECTION II DRUG DISCOVERY AND DEVELOPMENT

CHAPTER 4: DRUG DISCOVERY: DESIGN AND DEVELOPMENT

RONALD R. COBB & LESLIE J. MOLONY

INTRODUCTION

TARGETED MEDICINES AND THEIR IMPLICATIONS

DESIGNING A DRUG DISCOVERY PROJECT

WHOLE TISSUE STUDIES

OTHER SOURCES OF COMPOUNDS

SUMMARY

REFERENCES

CHAPTER 5: TRANSLATIONAL MEDICINE, PHARMACEUTICAL PHYSICIANS, PATIENTS, AND PAYERS

ROBERT SANDS & DOUGLAS ROY

INTRODUCTION

PHARMACEUTICAL MEDICINE AND THE R&D PRODUCTIVITY GAP

TRANSLATION OF SCIENCE—AN OVERVIEW

TRANSLATION OF GENOMICS INTO CLINICAL PRACTICE

TRANSLATIONAL MEDICINE AND DRUG DEVELOPMENT

PHASE 0 STUDIES

ADAPTIVE TRIAL DESIGNS

BIOMARKERS

TRANSLATION OF INNOVATION AND INTERDISCIPLINARY SKILLS

TRAINING FOR TRANSLATIONAL MEDICINE

CONCLUSION

ACKNOWLEDGEMENT

REFERENCES

CHAPTER 6: PHARMACEUTICS

ANTHONY W. FOX

INTRODUCTION

THE CONSTITUENTS OF A MEDICINE

FORMULATION CHOICE

SPECIFIC FORMULATIONS

STABILITY TESTING

INNOVATION IN PHARMACEUTICS

SUMMARY

REFERENCES

CHAPTER 7: NONCLINICAL TOXICOLOGY

FREDERICK RENO

CONSIDERATIONS RELATED TO THE CLINICAL DEVELOPMENT PLAN

CONSIDERATION OF REGULATORY STRATEGY

TOXICOLOGICAL SUPPORT PRE-IND AND FOR PHASE I CLINICAL STUDIES

TOXICOLOGICAL SUPPORT FOR PHASE II AND III STUDIES

NDA REQUIREMENTS

SUMMARY

REFERENCES

CHAPTER 8: INFORMED CONSENT

ANTHONY W. FOX

INTRODUCTION

ETHICAL BASIS

WRITTEN INFORMED CONSENT

UNWRITTEN INFORMED CONSENT

RESPONSIBILITY OF PARTIES TO INFORMED CONSENT

UNSETTLED ISSUES

MARKETED PRODUCTS

FURTHER READING

CHAPTER 9: PHASE I: THE FIRST OPPORTUNITY FOR EXTRAPOLATION FROM ANIMAL DATA TO HUMAN EXPOSURE

STEPHEN H. CURRY, HELEN H. DECORY, & JOHAN GABRIELSSON

THE IN VITRO/IN VIVO PREDICTION

PREDICTION FROM ANIMALS TO HUMANS IN VIVO

PHARMACOKINETIC/PHARMACODYNAMIC MODELS

COMMENTARY

PROSPECTUS

FURTHER READING

REFERENCES

CHAPTER 10: PHASE II AND PHASE III CLINICAL STUDIES

ANTHONY W. FOX

THE PHASES OF DRUG DEVELOPMENT: AN OBSOLETE MODEL?

CONCEPTS OF BIAS AND STATISTICAL NECESSITIES

PROSPECTIVE DEFINITIONS: THE ONLY WAY TO INTERPRET WHAT YOU MEASURE

HISTORICAL CLINICAL TRIALS

LIMITATIONS OF CONTROLLED CLINICAL TRIALS

THE CLINICAL DEVELOPMENT PLAN

PROTOCOLS, CASE-REPORT FORMS, AND INVESTIGATORS’ BROCHURES

OBJECTIVES AND PRE-REQUISITES OF PHASE II STUDIES

COMMON PHASE II/III STUDY DESIGNS

MINIMIZATION TRIALS

STRATIFICATION DESIGNS AND THE LARGE SIMPLE STUDY

TREATMENT WITHDRAWAL AND OTHER SPECIALIZED DESIGNS

STOPPING CLINICAL TRIALS

BAYESIAN TRIAL DESIGNS

SERIES OF PUBLISHED CASES

OBJECTIVES AND PRE-REQUISITES OF PIVOTAL CLINICAL TRIALS

BENEFIT–RISK ANALYSIS

SUMMARY

REFERENCES

CHAPTER 11: PHASE IV DRUG DEVELOPMENT: POST-MARKETING STUDIES

LISA R. JOHNSON-PRATT

OBJECTIVES OF THE PHASE IV CLINICAL DEVELOPMENT PROGRAM

TYPES OF PHASE IV STUDIES

THE CLINICAL–MARKETING INTERFACE

THE CLINICAL–LEGAL INTERFACE

CONCLUSION

REFERENCES

CHAPTER 12: SITE MANAGEMENT

BARRY MISKIN

INTRODUCTION

TYPES OF INVESTIGATIVE SITES

BASIC INFRASTRUCTURE

CLINICAL SITE CHALLENGES

FINAL THOUGHTS

REFERENCES

CHAPTER 13: GOOD CLINICAL PRACTICES

LIONEL D. EDWARDS

THE CURRENT RULES FOR CONDUCTING CLINICAL RESEARCH

SETTING UP CLINICAL STUDIES

ETHICAL CONSIDERATIONS

MONITORING AND SAFETY ASSESSMENT

COLLECTING DATA WITH INTEGRITY

MANAGING STUDY MEDICATIONS/DEVICES

SUMMARY

SOURCES OF INTERNATIONAL GUIDELINES/REGULATIONS FOR GCP

UNITED STATES

WHO

OTHER RELATED PUBLICATIONS

CHAPTER 14: QUALITY ASSURANCE, QUALITY CONTROL AND AUDIT

RITA HATTEMER-APOSTEL

INTRODUCTION

QUALITY MANAGEMENT

IMPLEMENTING QUALITY ASSURANCE

SCOPE OF QA ACTIVITIES

AUDITS FROM A TO Z

BRIEF OUTLINE OF AUDIT TYPES

CONCLUSION

REFERENCES

CHAPTER 15: THE UNIQUE ROLE OF OVER-THE-COUNTER MEDICINE

PAUL STARKEY

THE EXPANDING PLACE OF SELF-MEDICATION

DIFFERING STYLES OF OVER-THE-COUNTER DISTRIBUTION

CRITERIA FOR OTC USE OF MEDICINES

THE UNIQUE CHARACTERISTICS OF THE OTC FIELD FROM THE SPONSOR’S VIEWPOINT

PRESCRIPTION-TO-OTC SWITCH

SPECIAL STUDY DESIGNS FOR THE OTC AREA

MARKET SUPPORT STUDIES

SUMMARY

SECTION III SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES

INTRODUCTION

CHAPTER 16: DRUG RESEARCH IN OLDER PATIENTS

LIONEL D. EDWARDS

DEMOGRAPHICS

IMPACT OF AN AGEING POPULATION ON THE SOCIETY

PRESCRIBING AND ADVERSE EVENTS

PRACTICAL AND ETHICAL ISSUES OF DRUG RESEARCH IN OLDER POPULATIONS

REGULATORY RESPONSE

OVERVIEW OF INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINE

INDUSTRY RESPONSE

ISSUES OF DISEASES IN THE ELDERLY

ISSUES IN THE CONDUCT OF CLINICAL STUDIES IN THE ELDERLY

CONCLUSION

REFERENCES

CHAPTER 17: DRUG DEVELOPMENT RESEARCH IN WOMEN

LIONEL D. EDWARDS

BACKGROUND

THE DILEMMAS

THE PHANTOM FETUS

INDUSTRY PRACTICE: FACTORS IN PHASE I AND EARLY PHASE II TESTING

DRUG HANDLING DIFFERENCES BETWEEN MALES AND FEMALES

GOVERNMENT AGENCY AND INDUSTRY ACTIONS ON GENDER-RELATED RESEARCH

POSSIBLE SOLUTIONS

CONCLUSION

ACKNOWLEDGMENT

RECOMMENDED READING

REFERENCES

CHAPTER 18: CLINICAL RESEARCH IN CHILDREN

LIONEL D. EDWARDS

BACKGROUND

CHILDREN, THE THERAPEUTIC ORPHANS

1994 AND 1998 FINAL RULES ON PEDIATRIC STUDIES (FEDERAL REGISTER, 1994, 1998)

MAJOR PHYSIOLOGIC VARIATIONS IN PEDIATRICS

CLINICAL STUDIES

CONCLUSION

REFERENCES

CHAPTER 19: RACIAL AND ETHNIC ISSUES IN DRUG REGULATION

LIONEL D. EDWARDS, J-M. HUSSON, E. LABBÉ, C. NAITO, M. PAPALUCA AMATI, S. WALKER, R.L., WILLIAMS, & H. YASURHARA

BACKGROUND

REGULATORY PRACTICE

OBJECTIVE DIFFERENCES

THE EVOLUTION OF ICH TOPIC E5 BACKGROUND

THE FUTURE

RECOMMENDED FURTHER READING

SUGGESTED FURTHER READING

REFERENCES

CHAPTER 20: SPECIAL POPULATIONS: HEPATIC AND RENAL FAILURE

ANTHONY W. FOX

GENERAL PRINCIPLES

RENAL INSUFFICIENCY

HEPATIC INSUFFICIENCY

CHAPTER 21: DRUG INTERACTIONS

ANTHONY W. FOX & ANNE-RUTH VAN TROOSTENBURG

DEFINITION

DESCRIPTION AND QUANTITATION OF DRUG INTERACTIONS

SYSTEMATIC CONSIDERATION OF DRUG INTERACTIONS

PRECLINICAL INVESTIGATIONS AND CLINICAL TRIALS TO INVESTIGATE INTERACTIONS

REGULATORY CONSIDERATIONS OF DRUG INTERACTIONS

CHAPTER 22: ORPHAN DRUGS

BERT SPILKER

INTRODUCTION

PRINCIPLES

CLASSIFICATION OF ORPHAN DRUGS

ECONOMIC CLASSIFICATION OF ORPHAN DRUGS

THE INTERESTED PARTIES

SOURCES OF INFORMATION ON ORPHAN DRUGS

DISCOVERY, DEVELOPMENT, MARKETING, AND DISTRIBUTION OF ORPHAN DRUGS

MARKETING BENEFITS TO SELLING ORPHAN DRUGS

COMMON ISSUES FOR A COMPANY TO CONSIDER WHEN DEVELOPING AN ORPHAN DRUG

BENEFITS OF ORPHAN DRUGS FROM A DEVELOPMENT PERSPECTIVE

DISINCENTIVES AND OBSTACLES FOR ORPHAN DRUG DEVELOPMENT

THE UNITED STATES ORPHAN DRUG ACT OF 1983

UNINTENDED CONSEQUENCES OF THE ORPHAN DRUG ACT

ESTABLISHING PREVALENCE OR INCIDENCE OF A DISEASE

ESTABLISHING DIFFERENCES AMONG MEDICINES

WHAT IS AN ORPHAN DRUG INDICATION?

RATING THE EFFECTS OF THE ORPHAN DRUG ACT IN THE UNITED STATES

LESSONS OF THE ORPHAN DRUG ACT FOR EUROPE

REFERENCES

CHAPTER 23: QT INTERVAL PROLONGATION AND DRUG DEVELOPMENT

BRUCE H. MORIMOTO & ANTHONY W. FOX

INTRODUCTION

HISTORICAL CONTEXT AND REGULATORY REACTIONS

APPROACH TO RISK ASSESSMENT

NONCLINICAL EVALUATION TECHNIQUES

CLINICAL TESTING: HUMAN THOROUGH QT STUDY

SPONTANEOUS LONG QT SYNDROME

FUTURE CONSIDERATIONS

FURTHER READING

REFERENCES

SECTION IV APPLIED ASPECTS

INTRODUCTION

CHAPTER 24: BIOTECHNOLOGY PRODUCTS AND THEIR DEVELOPMENT

DAVID A. SHAPIRO & ANTHONY W. FOX

INTRODUCTION

DEFINITIONS

REGULATORY CONSIDERATIONS

BIOTECHNOLOGY VERSUS CONVENTIONAL DRUG PRODUCTS

MANUFACTURING ISSUES

PRODUCT CLASSES AND RESULTANT CLINICAL TRIAL ISSUES

GENE THERAPY

“FOLLOW-ON” BIOLOGICALS

CELL AND TISSUE PRODUCTS

GENERAL ETHICAL ISSUES

FURTHER READING

REFERENCES

CHAPTER 25: HEALTH ECONOMICS

DANIEL C. MALONE, EDWARD P. ARMSTRONG, & MIRZA I. RAHMAN

INTRODUCTION

HEALTH POLICY AND THE PHARMACEUTICAL INDUSTRY

GUIDELINES AND REGULATORY GUIDANCE

HEALTH TECHNOLOGY ASSESSMENT ORGANIZATIONS

PRINCIPLES OF HEALTH ECONOMIC ASSESSMENTS

HEALTH ECONOMIC METHODS

CAVEATS FOR HEALTH ECONOMIC STUDIES

REFERENCES

CHAPTER 26: PHARMACOECONOMICS: ECONOMIC AND HUMANISTIC OUTCOMES

RAYMOND J. TOWNSEND, JANE T. OSTERHAUS, & J. GREGORY BOYER

OUTCOMES, HEALTH ECONOMICS, AND PHARMACOECONOMICS

NEW PARADIGM: THREE-DIMENSIONAL OUTCOME ASSESSMENT

PHARMACOECONOMICS IN DEVELOPMENT PROGRAMS: ADVANTAGES, DISADVANTAGES, AND CHALLENGES

VALUE-ADDED VERSUS TRADITIONAL CLINICAL DEVELOPMENT PROGRAMS

PHARMACOECONOMIC BASELINE

STUDIES WITHIN CLINICAL TRIALS: TECHNIQUES

REPORTING AND PUBLICATIONS

CURRENT AND FUTURE USES OF PHARMACOECONOMIC OUTCOMES

FURTHER READING

REFERENCES

CHAPTER 27: PHARMACOEPIDEMIOLOGY AND THE PHARMACEUTICAL PHYSICIAN

HUGH H. TILSON

EPIDEMIOLOGY

EPIDEMIOLOGIC METHODOLOGIES

DRUG RISK AS AN EPIDEMIOLOGIC PROBLEM

THE “WIRED” EPIDEMIOLOGIST

DEFINITIONS

EPIDEMIOLOGY IN DRUG DEVELOPMENT

EPIDEMIOLOGY IN DRUG REGISTRATION AND LICENSING

THE EMERGING WORLD OF RISK MANAGEMENT

BALANCING BENEFITS AGAINST RISKS

TRAINING TO BE A PHARMACOEPIDEMIOLOGIST

THE FUTURE

REFERENCES

CHAPTER 28: STATISTICAL PRINCIPLES AND APPLICATION IN BIOPHARMACEUTICAL RESEARCH

DAN ANBAR

THE SCIENTIFIC METHOD AND THE ROLE OF THE SCIENTIFIC EXPERIMENT

THE STATISTICAL METHOD: MAKING DECISIONS UNDER CONDITIONS OF UNCERTAINTY

THE STATISTICAL TEST: THE NULL HYPOTHESIS, ERROR PROBABILITIES, STATISTICAL POWER

CAUSALITY

VARIABILITY: THE SOURCE OF UNCERTAINTY

THE CONTROLLED CLINICAL TRIAL: BASIC DESIGN ELEMENTS

THE STUDY POPULATION: INCLUSION AND EXCLUSION CRITERIA

THE STATISTICAL MODEL

STATISTICAL INFERENCE

STUDY DESIGN: DETERMINING THE SAMPLE SIZE

ISSUES IN STATISTICAL TRIAL DESIGN

ISSUES IN DATA ANALYSIS

THE DISSEMINATION OF CLINICAL TRIALS RESULTS

THE STATISTICIAN’S ROLE

EPILOGUE

FURTHER READING

REFERENCES

CHAPTER 29: DATA MANAGEMENT

T.Y. LEE, MICHAEL MINOR, & LIONEL D. EDWARDS

OBTAINING THE PROJECT MATERIAL

FORMATION OF THE PROJECT TEAM

PROJECT SETUP

DATA PROCESSING

INTERACTIVE VOICE RESPONSE SYSTEM (IVRS) AND ELECTRONIC DATA CAPTURE (EDC)

REFERENCES

CHAPTER 30: PATIENT COMPLIANCE: PHARMIONICS, A NEW DISCIPLINE

DR. JEAN-MICHEL MÉTRY

SUMMARY

PHARMIONIC TERMINOLOGY AND DEFINITIONS

INTRODUCTION

WHAT DOES “COMPLIANCE” REALLY MEAN?

METHODS OF EVALUATING COMPLIANCE

COMPLIANCE DURING CLINICAL TRIALS

STANDARDS FOR ANALYZING REAL-TIME COMPLIANCE

HOW IS COMPLIANCE CLASSIFIED: TYPICAL PATTERN

WHICH FORMS OF PARTIAL COMPLIANCE AND NONCOMPLIANCE ARE PARTICULARLY RELEVANT?

ACTIONS TO ENHANCE COMPLIANCE AND PERSISTENCE

WHAT IS THE RELEVANCE OF COMPLIANCE IN DAILY PRACTICE?

WHAT SHOULD INTERACTIVE PACKAGING OFFER TO IMPROVE PATIENT COMPLIANCE?

WHAT WILL BE THE REACTION OF THIRD-PARTY PAYERS?

CONCLUSION

REFERENCES

CHAPTER 31: MONITORING DRUG CONCENTRATIONS IN CLINICAL PRACTICE

ANTHONY W. FOX

GENERAL PRINCIPLES OF THERAPEUTIC MONITORING

WHY MONITOR DRUG CONCENTRATIONS?

MAXIMIZING PROBABILITY OF EFFICACY

ANTI-EPILEPTIC DRUGS

SALICYLATES

WHEN IS PLASMA CONCENTRATION MONITORING IRRATIONAL?

CONCENTRATION MONITORING IN OTHER BIOLOGICAL FLUIDS

SUMMARY

REFERENCES

CHAPTER 32: GENERICS

GABRIEL LOPEZ & THOMAS HOXIE

THE GREAT COMPROMISE: HISTORY OF GENERICS VERSUS BIG PHARMA IN THE US

SEEKING GENERIC APPROVAL IN THE UNITED STATES

GENERIC APPROVAL PROCESS OUTSIDE THE UNITED STATES

BIOPHARMACEUTICALS

BLURRING THE LINES

THE FUTURE

CHAPTER 33: COMPLEMENTARY MEDICINES

ANTHONY W. FOX

COMMON COMPLEMENTARY MEDICINES

ADVERSE EFFECTS DUE TO COMPLEMENTARY THERAPIES

REGULATORY ASPECTS

FURTHER READING

REFERENCES

SECTION V DRUG REGULATION

INTRODUCTION

CHAPTER 34: UNITED STATES REGULATIONS

WILLIAM KENNEDY & LIONEL D EDWARDS

THE FOOD AND DRUG ADMINISTRATION: HOW WE GOT WHERE WE ARE

ECONOMIC CONSIDERATIONS

ORGANIZATIONAL ASPECTS

INVESTIGATIONAL NEW DRUGS (IND)

MEETINGS WITH THE FDA

THE NEW DRUG APPLICATION (NDA)

SOURCES OF GUIDANCE

INFLUENCES ON FDA ACTIVITIES

DEVELOPMENTS FROM 2005

SUMMARY

CHAPTER 35: SPECIAL US REGULATORY PROCEDURES: EMERGENCY AND “COMPASSIONATE” INDS AND ACCELERATED PRODUCT APPROVALS

ANTHONY W. FOX

INTRODUCTION

EMERGENCY INDS

“EXPANDED ACCESS” AND THE TREATMENT IND

ACCELERATED APPROVALS: SERIOUS AND LIFE-THREATENING DISEASES

ACCELERATED APPROVALS: ANDAS AND GENERIC DRUGS

FURTHER READING

REFERENCES

CHAPTER 36: THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE FROM CLASSICAL TIMES TO THE 21ST CENTURY

JOHN P. GRIFFIN

THE EVOLUTION OF HUMAN MEDICINES CONTROL FROM A NATIONAL TO AN INTERNATIONAL PERSPECTIVE

THE 19TH AND 20TH CENTURIES TO THE MEDICINES ACT 1968

THALIDOMIDE AND ITS AFTERMATH

THE EUROPEAN CONTROLS OF MEDICINAL PRODUCTS

CONCLUSION

RECOMMENDED INFORMATION SOURCES

REFERENCES

CHAPTER 37: MEDICINES REGULATION IN THE EUROPEAN UNION

A-R. VAN TROOSTENBURG & G. TABUSSO

LIST OF ABBREVIATIONS

THE EUROPEAN REGULATORY FRAMEWORK

THE EUROPEAN LEGISLATIVE MECHANISM

THE LEGAL BASIS FOR MEDICINAL PRODUCT MARKETING AUTHORIZATION

THE INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH) PROCESS

THE EUROPEAN MEDICINES AGENCY (EMA)

CURRENT EUROPEAN REGULATORY PRACTICE

SCIENTIFIC ADVICE AND PROTOCOL ASSISTANCE

THE EU PEDIATRIC REGULATION

MARKETING AUTHORIZATION

ORPHAN MEDICINAL PRODUCTS

GENERIC MEDICINAL PRODUCTS

HERBAL MEDICINAL PRODUCTS

LABELING

MARKETING AUTHORIZATION VARIATIONS, RENEWALS, AND RECLASSIFICATION

SAFETY REPORTING AND PHARMACOVIGILANCE

REGULATION OF ADVERTISING AND PROMOTION

PROSPECTIVE OF EU MEDICINES REGULATION

MEDICINES REGULATION IN SWITZERLAND

MEDICAL DEVICES AND DRUG/DEVICE COMBINATIONS

FURTHER READING

CHAPTER 38: JAPANESE REGULATIONS

ETIENNE LABBÉ

ORGANIZATION OF JAPANESE HEALTH AUTHORITIES

JAPANESE PHARMACEUTICAL LAWS

DRUG DEVELOPMENT REGULATIONS OVERVIEW

DRUG DEVELOPMENT PROCEDURES

NEW DRUG APPROVAL PROCESS

POST-APPROVAL ACTIVITIES

CONCLUSION

REFERENCES

FURTHER READING

CHAPTER 39: DRUG REGISTRATION AND PRICING IN THE MIDDLE EAST

EDDA FREIDANK-MUESCHENBORN & ANJA KÖNIG

THE MARKET

COMPANY AND PRODUCT REGISTRATION

SUMMARY

APPENDIX: APPLICATION PROCESSES

FURTHER READING

CHAPTER 40: CHINA’S REGULATED PHARMACEUTICAL MARKET

YAN YAN LI STARKEY

INTRODUCTION

CHINA HAS BECOME THE FASTEST GROWING PHARMACEUTICAL MARKET

GOVERNMENT SUPPORT TO DEVELOP INFRASTRUCTURE AND THE HEALTHCARE SYSTEM

AGEING AND URBANIZATION WITH A SHIFT TO NON-COMMUNICABLE DISEASES PROVIDE LARGE PATIENT POOLS

ATTRACTIVE COST/QUALITY MIX

INTEGRATED R&D CENTERS IN CHINA FACILITATE INNOVATION IN DRUG DEVELOPMENT

CRO INDUSTRIES ARE ON A FAST-GROWTH TRACK IN CHINA

OVERVIEW OF REGULATORY IND AND NDA IN CHINA

INTELLECTUAL PROPERTY RIGHTS ARE IMPROVING

OTC MARKET

SUMMARY

FURTHER READING

REFERENCES

CHAPTER 41: INDIA’S NEW ERA IN PHARMACEUTICALS

DARSHAN KULKARNI

INTRODUCTION

DOMESTIC PHARMACEUTICAL INDUSTRY

INTERNATIONAL POTENTIAL

CURRENT TOPICS

CONCLUSION

SECTION VI MEDICAL SERVICES

INTRODUCTION

CHAPTER 42: MEDICAL AFFAIRS

GREGORY P. GEBA

INTRODUCTION

PHASE III AND PHASE IIIB STUDIES

PHASE IV STUDIES

DATA MINING IN THE PHASE IV ENVIRONMENT

PRACTITIONER AND INVESTIGATOR INTERACTION

ACCESS TO ONGOING CLINICAL TRIAL INFORMATION

SUMMARY

FURTHER READING

USEFUL WEBSITES

CHAPTER 43: DRUG LABELING

ANTHONY W. FOX

INTRODUCTION

DRUG LABELING IN JAPAN

DRUG LABELING IN THE UNITED STATES

EUROPEAN LABELING

FINAL WORDS

FURTHER READING

REFERENCES

CHAPTER 44: DATA MINING

MIRZA I. RAHMAN & ROBBERT P. VAN MANEN

INTRODUCTION

METHODS

SAFETY SURVEILLANCE

DATA MINING IN SAFETY SURVEILLANCE

CASE STUDY

REGULATORY GUIDANCE

PRIVACY

LIMITATIONS

SUMMARY

FURTHER READING

REFERENCES

CHAPTER 45: RISK MANAGEMENT IN PRODUCT APPROVAL AND MARKETING

ANTHONY W. FOX

WHAT IS RISK MANAGEMENT?

REGULATORY FRAMEWORKS

PRACTICAL EXAMPLES

SUMMARY

ACKNOWLEDGMENTS

FURTHER READING

REFERENCES

CHAPTER 46: PUBLISHING CLINICAL STUDIES

ANTHONY W. FOX

INTRODUCTION

ETHICS IN PUBLISHING CLINICAL TRIALS

DESIRABILITY OF, AND BIASES, IN THE PUBLICATION OF CLINICAL TRIALS

THE CLASSIC COMPONENTS OF A CLINICAL TRIAL REPORT IN A PEER-REVIEWED JOURNAL

SUMMARY AND PROSPECTUS

REFERENCES

CHAPTER 47: ORGANIZING AND PLANNING LOCAL, REGIONAL, NATIONAL, AND INTERNATIONAL MEETINGS AND CONFERENCES

ZOFIA DZIEWANOWSKA & LINDA PACKARD

GOALS, TYPES OF MEETINGS, AND PARTICIPANTS

SUMMARY

CHAPTER 48: WHEN THINGS GO WRONG: DRUG WITHDRAWALS FROM THE MARKET

RONALD D. MANN

INTRODUCTION

PREVENTION IS BETTER THAN CURE

“WHEN THE BALLOON GOES UP”

ESCAPING FROM THE MAZE

REFERENCES

CHAPTER 49: INTERNATIONAL TRIALS: SUCCESSFUL PLANNING AND CONDUCT

KATIE P.J. WOOD

WHY DO INTERNATIONAL STUDIES AT ALL?

DOCUMENTATION, STANDARD OPERATING PROCEDURES (SOPS), AND GLOBALIZATION

FURTHER READING

USEFUL WEBSITES

REFERENCES

SECTION VII LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE

INTRODUCTION

CHAPTER 50: INTRODUCTION TO BIOETHICS FOR PHARMACEUTICAL PROFESSIONALS

ANDREW J. FLETCHER

INTRODUCTION

BASIC TOOLS OF BIOETHICS

ETHICS OF HUMAN EXPERIMENTATION

ETHICS OF ANIMAL EXPERIMENTATION

FURTHER ISSUES OF CONCERN TO THE PHARMACEUTICAL INDUSTRY AND MEDICAL RESEARCH

REFERENCES

CHAPTER 51: PHARMACEUTICAL MEDICINE AND THE LAW

SARAH CROFT

INTRODUCTION

INDIVIDUAL OR CORPORATE RESPONSIBILITY?

CRIMINAL AND CIVIL LAW DISTINGUISHED

CRIMINAL LAW

CIVIL LAW

THE LEGAL FRAMEWORK FOR REGULATING PHARMACEUTICAL PRODUCTS

LEGAL PROCEDURES

DATA PROTECTION

PHARMACEUTICAL INDUSTRY VOLUNTARY CODES

CONCLUSION

CHAPTER 52: FRAUD AND MISCONDUCT IN CLINICAL RESEARCH

JANE BARRETT

INTRODUCTION

HOW COMMON IS RESEARCH FRAUD?

FRAUD OR MISCONDUCT?

WHAT CONSTITUTES RESEARCH FRAUD?

WHAT IS BEING DONE ABOUT HANDLING RESEARCH FRAUD?

WHY COMMIT RESEARCH FRAUD?

WHAT HAS BEEN THE IMPACT OF EUROPEAN LEGISLATION?

WHAT CAN BE DONE TO PREVENT FRAUD?

WHAT CAN BE DONE IF FRAUD IS SUSPECTED?

CONCLUSIONS

REFERENCES

SECTION VIII BUSINESS ASPECTS

INTRODUCTION

CHAPTER 53: THE MULTINATIONAL CORPORATIONS: CULTURAL CHALLENGES, THE LEGAL/REGULATORY FRAMEWORK AND THE MEDICO-COMMERCIAL ENVIRONMENT

R. DRUCKER & R. GRAHAM HUGHES

CULTURAL CHALLENGES

THE LEGAL/REGULATORY FRAMEWORK FOR DRUG DEVELOPMENT IN EUROPE AND THE UNITED STATES

THE MEDICO-COMMERCIAL ENVIRONMENT IN THE UNITED STATES AND EUROPE

FURTHER READING

CHAPTER 54: ADVERTISING AND MARKETING

JONATHAN BELSEY

WHAT IS MARKETING?

PHARMACEUTICALS ARE DIFFERENT FROM OTHER PRODUCTS

PRODUCT VERSUS BRAND

THE CUSTOMERS

THE PRODUCT LIFE CYCLE

REGULATIONS REGARDING MARKETING OF PRESCRIPTION DRUGS

MARKETING BUDGETS

STRATEGIES

ADVERTISEMENTS IN MEDICAL JOURNALS

DETAILING TO PRESCRIBERS

FREE SAMPLES AND GIFTS

DIRECT-TO-CONSUMER ADVERTISING

DISEASE AWARENESS CAMPAIGNS

INTERNET MARKETING

PATIENT SUPPORT GROUPS

MEDICAL EDUCATION ACTIVITIES

CONCLUSIONS

REFERENCES

CHAPTER 55: PHARMACEUTICAL PRODUCT LIABILITY

HAN W. CHOI & JAE HONG LEE

PRINCIPLES OF PRODUCT LIABILITY LAW

TYPES OF PRODUCT DEFECTS

LEGAL DEFENSES IN PRODUCT LIABILITY CASES

INTERNATIONAL ISSUES

LANDMARK CASES

RECENT CASES AND DEVELOPMENTS

CONCLUSIONS

REFERENCES

CHAPTER 56: PATENTS

GABRIEL LOPEZ

INTELLECTUAL PROPERTY

SHORT HISTORY OF PATENTS

PATENT PROTECTION

PATENTABLE SUBJECT MATTER

CRITERIA FOR OBTAINING A PATENT

SHORT BIOGRAPHY OF A PATENT APPLICATION

INTERNATIONAL TREATIES

INTERFERENCE PRACTICE

BIOTECHNOLOGY

THE VALUE OF PATENTS

CHAPTER 57: OUTSOURCING CLINICAL DRUG DEVELOPMENT ACTIVITIES TO CONTRACT RESEARCH ORGANIZATIONS (CROS): CRITICAL SUCCESS FACTORS

JOHN R. VOGEL

PHARMACEUTICAL INDUSTRY VIEWS OF CROS

DECIDING WHEN TO USE A CRO

FREQUENT CAUSES OF SPONSOR/CRO PROBLEMS

DETERMINE STUDY SPECIFICATIONS

SELECTING THE RIGHT CRO

REQUESTING AND EVALUATING PROPOSALS FROM CROS

MANAGING THE SPONSOR–CRO RELATIONSHIP

IDENTIFYING AND RESOLVING PROBLEMS

CONCLUSIONS

REFERENCES

CHAPTER 58: THE IMPACT OF MANAGED CARE ON THE US PHARMACEUTICAL INDUSTRY

ROBERT J. CHAPONIS, CHRISTINE HANSON-DIVERS, & MARILYN J. WELLS

THE CONCEPTS OF MANAGED CARE

THE IMPACT OF MANAGED CARE ON THE PHARMACEUTICAL INDUSTRY

EMERGING TRENDS IN MANAGED CARE AND THEIR IMPACT ON THE PHARMACEUTICAL INDUSTRY

SUMMARY

REFERENCES

APPENDIX: USEFUL WEB LINKS

REGULATORY LINKS

PHARMACEUTICAL-RELATED SOCIETIES

LINKS FOR NATIONAL ASSOCIATIONS OF PHARMACEUTICAL PHYSICIANS

OTHER MEDICAL SOCIETIES AND ORGANIZATIONS

PHARMACEUTICAL COMPANIES

CONTRACT RESEARCH ORGANIZATIONS

ETHICS IN CLINICAL RESEARCH

MISCELLANEOUS

Index

This edition first published 2011, © 2011 by Blackwell Publishing Ltd.

Blackwell Publishing was acquired by John Wiley & Sons in February 2007. Blackwell’s publishing program has been merged with Wiley’s global Scientific, Technical and Medical business to form Wiley-Blackwell.

Registered office: John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK

Editorial offices: 9600 Garsington Road, Oxford, OX4 2DQ, UKThe Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK111 River Street, Hoboken, NJ 07030-5774, USA

For details of our global editorial offices, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell

The right of the author to be identified as the author of this work has been asserted in accordance with the Copyright, Designs and Patents Act 1988.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher.

Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.

Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought.

The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of fitness for a particular purpose. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom.

Library of Congress Cataloging-in-Publication Data

Principles and practice of pharmaceutical medicine/edited by Lionel D.Edwards, Anthony W. Fox, Peter D. Stonier. – 3rd ed.p.; cm.Includes bibliographical references and index.ISBN 978-1-4051-9472-31. Drug development. 2. Drugs–Research. 3. Pharmacology. I. Edwards, Lionel D. II. Fox, Anthony W., 1956- III. Stonier, P. D.[DNLM: 1. Drug Evaluation. 2. Drug Industry–organization & administration. QV 736]RM301.25.P75 2010615′.19–dc22

2010027197

Contributors

Anbar, DanDANA Pharmaceutical Consulting, Inc., NJ, USA Email: [email protected]

Armstrong, EdwardPharmacy Practice and Science, College of Pharmacy, University of Arizona, USA

Barrett, JaneGawsworth, Cheshire, UK Email: [email protected]

Belsey, JonathanJB Medical Ltd, Sudbury, Suffolk, UK Email: [email protected]

Boyer, J. GregoryAccreditation Council for Pharmacy Education, Chicago, ILL, USA

Chaponis, Robert J.Novartis, Parsippany, NJ, USA Email: [email protected]

Choi, Han W.Oracle Investment Management, Inc., Greenwich, CT, USA Email: [email protected]

Cobb, Ronald R.RiverWood BioConsulting Inc., Gainesville, FL, USA Email: [email protected]

Croft, SarahShook, Hardy and Bacon International LLP, London, UK Email: [email protected]

Curry, Stephen, H.University of Rochester, Rochester, NY, USA Email: [email protected]

DeCory, Helen H.Bausch and Lomb Inc.,Rochester, NY, USA

Drucker, R.Technomark Life Sciences LLP, Durham, NC, USA

Dziewanowska, ZofiaNew Drug Associates, Inc., La Jolla, CA, USA Email: [email protected]

Fletcher, Andrew J.Temple University School of Pharmacy, PHARM-QA/RA, Philadelphia, PA, USA Email: [email protected]

Freidank-Mueschenborn, EddaBungalowsiedlung 1 B, D-17406 Rankwitz, Germany

Gabrielsson, JohanAstraZeneca AB, Gothenburg, Sweden

Geba, Gregory P.Clinical Development, MedImmune, LLC, Gaithersburg, MD Email: [email protected]

Griffin, John P.Asklepieion Consultancy Ltd, Welwyn, Hertfordshire, UK Email: [email protected]

Sheila GwizdakPfizer Inc., New London, CT, USA

Hanson-Divers, ChristineAstraZeneca, Cary, NC, USA

Hattemer-Apostel, RitaVerdandi AG, 8049 Zurich, Switzerland Email: [email protected]

Hoxie, ThomasHoxie & Associates LLC, Millburn, NJ, USA

Husson, Jean-MarcParis, France

Hughes, R. GrahamConsultant in Pharmaceutical Development, Merlimont, France

Johnson-Pratt, Lisa R.Bryn Mawr, PA, USA Email: lisa [email protected]

Kennedy, William

König, AnjaEngelhard Arzneimittel AG, Niederdorfelden, Germany

Kulkarni, DarshanThe Kulkarni Law Firm, Philadelphia, PA, USA Email: [email protected]

Labbé, EtienneUCB S.A., Brussels, Belgium

Lee, Jae HongMorrison & Foerster LLP, San Diego, CA, USA Email: [email protected]

Lee, T.Y.Clinical Development and Asian Ventures, Kendle International Inc.,Cincinnati, OH, USA

Lopez, GabrielBasking Ridge, NJ, USA Email: [email protected]

Malone, DanielPharmacy Practice and Science, College of Pharmacy, University of Arizona, USA

van Manen, RobbertHealth Economics and Clinical Outcomes Research, Medical Affairs, Centocor Inc., Horsham, PA, USA

Mann, RonaldUniversity of Southampton, Hants, UK Email: [email protected]

Marks, PeterPfizer Limited, Sandwich, Kent, UK Email: [email protected]

Métry, Jean-Michel (Deceased)

Minor, MichaelClinical Development and Asian Ventures, Kendle International Inc., Cincinnati, OH, USA

Miskin, BarryDepartment of Surgery, Nova Southeastern University, College of Osteopathic Medicine, Fort Lauderdale – Davie, Florida, USA Email: [email protected]

Molony, Leslie J.Transgeneron Therapeutics, Inc., Gainesville, FL, USA Email: [email protected]

Morimoto, Bruce H.Allon Therapeutics Inc., Redwood City, CA, USA Email: [email protected]

Naito, C.Teikyo University, Tokyo, Japan

Osterhaus, Jane T.Wasatch Health Outcomes, Park City, UT, USA Email: [email protected]

Packard, LindaAmerican Academy of Pharmaceutical Physicians, Research Triangle Park, NC, USA

Papaluca Amati, MarisaEuropean Agency for the Evaluation of Medicinal Products, London, UK

Rahman, Mirza I.Health Economics and Reimbursement, Evidence Based Medicine, Ortho-Clinical Diagnostics, Inc., Rochester, NY, USA Email: [email protected]

Reno, Fred (retired)Merritt Island, FL, USA

Roy, DouglasDivision of Pathway Medicine, Medical School, University of Edinburgh, Edinburgh, UK

Sands, RobertSanofi-aventis, Cambridge, MA, USA Email: [email protected]

Shapiro, David A.Intercept Pharmaceuticals, San Diego, CA, USA Email: [email protected]

Spilker, BertBert Spilker Associates, Bethesda, MD, USA Email: [email protected]

Starkey, Paul W.Merck Consumer Care, Whitehouse Station, NJ, USA Email: [email protected]

Starkey, Yan Yan LiGlaxoSmithKline Consumer Healthcare, Parsippany, NJ, USA Email: [email protected]

Tabusso, GiulianaMilan, Italy Email: [email protected]

Tilson, Hugh H.School of Public Health, University of North Carolina, Chapel Hill, NC, USA Email: hugh [email protected]

Townsend, Raymond J.Elan Pharmaceuticals, San Diego, CA, USA Email: [email protected]

van Troostenburg, Anne-RuthTakeda Group R&D, London, UK Email: [email protected]

Vogel, JohnJohn R. Vogel Associates Inc., Kihei, HI, USA Email: [email protected]

Walker, StuartCentre for Medicines Research, International Institute for Regulatory Science, London UK Email: [email protected]

Wells, Marilyn J.East Stroudsburg University, East Stroudsburg, PA, USA

Williams, Roger L.US Pharmacopia, Rockville, MD, USA

Wood, Katie P.J.Foster City, CA, USA Email: [email protected]

Yasurhara, H.Teikyo University, Tokyo, Japan

Young, MichaelMDY Associates, Philadelphia, PA, USA Email: [email protected]

Preface to the First Edition

Pharmaceutical medicine is a relatively new, but rapidly growing, academic discipline. As these trends continue into the 21st century, pharmaceutical physicians are increasingly regarding consultancy work and contract research organization (CRO) affiliation as good career opportunities, and now recognize the need for continuing education and training in this broad spectrum discipline.

As editors, we would like to thank our contributors for their expertise, their dedication, and their vision. We would like to thank and acknowledge the work and counsel of our colleague Robert Bell, MD, PhC, who helped us greatly during the early part of this project. We would also like to thank and acknowledge the enormous help, encouragement, and patience of the team at John Wiley & Sons, Ltd, UK, with whom we have worked closely over these past few years, among whom we have particularly stressed (!) Michael Davis, Deborah Reece, Hannah Bradley, Lewis Derrick, and Hilary Rowe.

Lastly, we would like to thank our families, and friends, who have withstood the frequent telephone calls, e-mails, and meetings, often late into the night. Indeed, to all who made this project possible, both authors and non-authors, we thank you. We are certain that this specialty, and our patients, even though we may help them vicariously, will benefit because of your contributions.

Andrew FletcherLionel EdwardsTony FoxPeter Stonier

Preface to the Second Edition

Since the first edition of this book, pharmaceutical medicine has only become more diverse and has also become widely accepted as a recognized medical specialty, for example, with its first graduates of specialist training in the United Kingdom, to add to those of Switzerland and Mexico. This has been accompanied by pharmaceutical medicine’s rapid progress toward specialty recognition within the European Community, and many changes in the pharmaceutical environment. So, we have taken this book further with this second edition. There are new chapters on European regulations, risk management, the Middle East, Asia, and other topical subjects in pharmaceutical medicine. Those chapters that did appear in the first edition have all been brought up to date.

But this book is for all those working in pharmaceutical medicine, regardless of their degrees, titles, or affiliations. Although it comprehensively covers the internationally harmonized syllabus for the Diplomas in Pharmaceutical Medicine that are awarded in Belgium, Switzerland, and the United Kingdom, this book will also usefully serve those teaching other types of certificates and (usually Master’s) degrees in this field, as well as being a vade mecum for those who are not undertaking academic courses.

We would again like to thank the team at John Wiley and Sons, Ltd, Chichester (UK). Hannah Bradley got this second edition started, but then went off on a tour around the world; the editors strenuously deny that they are the reason why. Lucy Sayer and Juliet Booker have since piloted the ship to the dock-side, successfully cajoling us into getting this edition done before its second decade. Not least, we would like to thank you, the reader, for your continued support and suggestions. So here is our second edition, it is more than a simple update, and it is even less US-centric than before.

Lionel EdwardsAndrew FletcherTony FoxPeter Stonier

Preface to the Third Edition

Pharmaceutical medicine is now practiced by people with a wider range of backgrounds than ever before. Clinical trials now demand the skills of ethicists, clinical pharmacologists, dental surgeons, medical practitioners, nurses, psychologists, regulators, and many others who will have attended diverse types of graduate and medical schools. This book is for all of them.

Pharmaceutical medicine is a discipline that is also spreading geographically. Not only are clinical trials now being conducted on a global scale, but also academic rigor in pharmaceutical medicine is being pursued in more and more countries. For example, we anticipate that during the currency of this edition the Diploma in Pharmaceutical Medicine, which began in the United Kingdom, either has already been or will have become established in Belgium, India, Mexico, South Africa, and Switzerland. In addition, there are well-established Master of Science degrees, covering much of the same syllabus, in most of the developed world. We have aimed this textbook to support all these academic endeavors.

Like the discipline itself, perseverance with our particular brand of editing has spread geographically during this third edition. We began with Lucy Sayer, who was bravely willing to take us on, yet again, from Portsmouth, UK. Then, one previously unpublished consequence of the merger of John Wiley and Sons with Blackwell Publishing was that Adam Gilbert, Robyn Lyons, and Gill Whitley accepted the awkward role of joining an ongoing project, while blissfully unaware of the cantankerous editors that came with it. But pressure is load divided by the area receiving it, and our load now is borne across a broad arc extending from Oxford, via London, to Normandy. We hope that this spreading of the load has reduced the megaPascals that we have created.

Other people deserve our thanks because this third edition would never have appeared without them. As before, these include Rob Bell MD, PhC and Andrew Fletcher MB BChir, MSc, DipPharmMedRCP, FFPM, both of whom were seminal to this project. Our families, too, are big indirect contributors.

But the reason that we have done this, now for the third time in a decade, is because of you, the reader, and through you, even if it is vicariously, foryourpatients.

Lionel EdwardsTony FoxPeter Stonier

About the Editors

Lionel D. Edwards, MB, BS, LRCP, MRCS, Dip COG, FFPM, is President of Pharma Pro Plus Inc., a drug development consulting company. Dr Edwards has been involved in all aspects of clinical trials for over 37 years on many different research drug and devices in 10 therapeutic areas. Previously, he was Senior Director at Novartis, a managing consultant at PA consulting, Vice President of Clinical Research at Bio-Technology Pharmaceutical Corporation, a small biotechnology firm operating both in the United States and internationally. Prior to this, he worked at Noven Inc., a small Skin Patch Technology firm with large International licensed partners: CIBA and Rhone Poulenc Rorer. He was Assistant Vice President, International Clinical Research at Hoffman-La Roche, Senior Director of Schering-Plough International Research, and Director of US Domestic Gastrointestinal, Hormonal, and OTC Research Departments. Dr Edwards chaired the PMA (PhRMA) Special Populations Committee, and also sat on the Institute of Medicine Committee for Research in Women, through the US National Institutes of Health. He also served on the Efficacy subcommittee Topic 5 (Acceptability of Foreign Clinical Data) for the International Committee on Harmonization (ICH) and contributed to the working paper on E Topic 1 (Research in Geriatric Patients). Dr Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a Founder member of the American Academy of Pharmaceutical Physicians now part of the Association of Clinical Research Professionals (ACRP). Dr Edwards has homes in New Jersey and Florida.