Principles and practice of pharmaceutical medicine / Andrew J. Fletcher ... [et al., editors].

Format:

Book

Contributor:

Fletcher, Andrew J.

Language:

English

Subjects (All):

Drug development.

Drugs--Research.

Drugs.

Pharmacology.

Physical Description:

xii, 541 pages : illustrations ; 25 cm

Other Title:

Pharmaceutical medicine

Place of Publication:

New York : Wiley, [2002]

Summary:

"Principles and Practice of Pharmaceutical Medicine "begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. The authors are all experts in their field and include an assessment of the current status of their specialities This book provides an insight into how things may develop in the future It is designed to be a guide for those who are actually practicing pharmaceutical medicine

Contents:

Section I Overview of Pharmaceutical Medicine

1 Pharmaceutical Medicine as a Medical Speciality / Michael D. Young 3

2 What Pharmaceutical Medicine Is and Who Does It / W. Wardell, Susan Toland, Anthony W. Fox 13

3 Competency-based Training System for Clinical Research Staff / Jay D. Miller 17

Section II Drug Discovery and Development

4 Drug Discovery: Design and Serendipity / Leslie J. Molony 31

5 Pharmaceutics / Anthony W. Fox 45

6 Non-clinical Toxicology / Frederick Reno 55

7 Informed Consent / Anthony W. Fox 65

8 Good Clinical Practices / Wendy Bohaychuk, Graham Ball 69

9 Quality Assurance, Quality Control and Audit / Donna Cullen 85

10 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Experience / Stephen Curry, Dennis McCarthy, Heleen H. DeCory Matthew Marler, Johan Gabrielsson 95

11 Phase II and Phase III Clinical Studies / Anthony W. Fox 117

12 Phase IV Drug Development: Post-marketing Studies / Lisa R. Johnson-Pratt 133

13 Over-the-counter Medicines / Paul Starkey 141

Section III Special Populations

14 Drug Research in Older Patients / Lionel D. Edwards 157

15 Drug Development Research in Women / Lionel D. Edwards 165

16 Clinical Research in Children / Lionel D. Edwards 183

Section IV Applied Aspects of Drug Development

17 Biotechnology Products and Their Development / David Shapiro, Anthony W. Fox 191

18 Orphan Drugs / Bert Spilker 203

19 Pharmacoeconomics: Economic and Humanistic Outcomes / Raymond J. Townsend, Jane T. Osterhaus, J. Gregory Boyer 211

20 Pharmacoepidemiology and the Pharmaceutical Physician / Hugh Tilson 223

21 Statistical Principles and Their Application in Biopharmaceutical Research / Dan Anbar 231

22 Data Management / T.Y. Lee, Michael Minor 259

23 Patient Compliance / Jean-Michel Metry 269

24 Complementary Medicines / Anthony W. Fox 281

Section V Drug Registration

25 United States Regulations / William Kennedy 289

26 Emergency and Compassionate-use INDs and Accelerated NDA or ANDA Approvals

Procedures, Benefits and Pitfalls / Anthony W. Fox 299

27 Japanese Regulations / Etienne Labbe 307

28 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 / John Griffin 325

29 Ethnic Issues in Drug Registration / Lionel D. Edwards, J.M. Husson, A. Kumagai, E. Labbe, C. Naito, M. Papaluca, S. Walker, R. Williams, M. Weintraub, H. Yasurhara 347

Section VI Medical Services

30 An Introduction to Medical Affairs / Gill Price 365

31 Drug Labeling / Anthony W. Fox 371

32 Organizing and Planning Local, Regional, National and International Meetings and Conferences / Zofia E. Dziewanowska, Linda Packard, Lionel D. Edwards 375

33 Drug Surveillance / Howard J. Dreskin, Win M. Castle 379

34 Disease Management

What Does It Mean? / Roy Lilley 389

35 Publishing Clinical Studies / Anthony W. Fox 403

Section VII Legal and Ethical Aspects

36 Pharmaceutical Product Liability / Han W. Choi, Howard B. Yeon 421

37 Patents / Gabriel Lopez 431

38 Fraud and Misconduct in Clinical Research / Frank Wells 441

Section VIII Business Aspects

39 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment / R. Drucker, R. Graham Hughes 453

40 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors / John R. Vogel 461

41 The Third World / Gamal Hammad 483

42 Financial Aspects of Clinical Trials / R. Graham Hughes, N. Turner 501

43 The Impact of Managed Care on the US Pharmaceutical Industry / Robert Chaponis, Christine Hanson-Divers, Marilyn J. Wells 513.

Notes:

Includes bibliographical references and index.

ISBN:

0471986550

OCLC:

46462793