Drug Safety Evaluation / Edition 2

Drug Safety Evaluation / Edition 2

by Shayne Cox Gad
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Drug Safety Evaluation / Edition 2

The updated and expanded safety guide to all aspects of the drug development process

Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated.

This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems.

Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are:

Acute toxicity testing in pharmaceutical safety evaluation


Safety assessment of inhalant drugs

Immunotoxicology in pharmaceutical development

Large animal studies

Evaluation of human tolerance and safety in clinical trials

More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Product Details

ISBN-13: 9780470253168
Publisher: Wiley
Publication date: 06/09/2009
Series: Pharmaceutical Development Series , #7
Edition description: Older Edition
Pages: 1200
Product dimensions: 6.40(w) x 9.40(h) x 2.30(d)

Table of Contents

Preface ix

Acknowledgment x

About the Author xi

1 Drug Development Process and Global Pharmaceutical Marketplace 1

2 Regulation of Human Pharmaceutical Safety 19

3 Prior Art and Its Use in Safety Assessment Process 89

4 Screens in Safety and Hazard Assessment 103

5 Formulations, Routes, and Dosage Design 121

6 Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation 185

7 Genotoxicity 234

8 Repeat-Dose Toxicity Studies 304

9 Immunotoxicology in Drug Development 326

10 Nonrodent Animal Studies 400

11 Developmental and Reproductive Toxicity Testing 441

12 Carcinogenicity Studies 481

13 Histopathology in Nonclinical Pharmaceutical Safety Assessment 520

14 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment 531

15 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation 568

16 Safety Pharmacology 619

17 Special Concerns for Preclinical Evaluation of Biotechnology Products 644

18 Safety Assessment of Inhalant and Dermal Route Drugs 688

19 Special-Case Products: Imaging Agents and Oncology Drugs 725

20 Occupational Toxicology in Pharmaceutical Industry 737

21 Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals 759

22 Application of In Vitro Techniques in Drug Safety Assessment 788

23 Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond 861

24 Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses 935

25 Statistics in Pharmaceutical Safety Assessment 972

26 Combination Products: Drugs and Devices 1083

27 Qualification of Impurities, Degradants,Residual Solvents, and Leachables in Pharmaceuticals 1100

Appendix A Selected Regulatory and Toxicological Acronyms 1117

Appendix B Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies 1121

Appendix C Notable Regulatory Internet Addresses 1125

Appendix D Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents 1133

Appendix E Common Vehicles for Nonclinical Evaluation of Therapeutic Agents 1140

Appendix F Global Directory of Contract Toxicology Laboratories 1161

Index 1171

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