Drug Safety Evaluation (eBook)

Shayne Cox Gad, BS, PhD, DABT, has more than 39 years of experience in regulatory toxicology, drug and device development, statistics, and risk assessment. He is Principal of Gad Consulting Services, a firm with eight employees and more than 500 clients worldwide in the pharmaceutical and medical device industries. He is Past President of the American College of Toxicology (ACT), the Roundtable of Toxicology Consultants, and three of the Society of Toxicology's specialty sections. Dr. Gad received the 2008 ACT Lifetime Contribution Award and has authored or edited 47 books (10 with Wley) and more than 350 chapters, articles, and abstracts. Has preparated 110 INDs and 8 NDAs and teaches 3-5 professional education courses a year.

Preface: ix

About the Author xi

Chapter 1: The Drug Development Process and the Global Pharmaceutical Marketplace

Chapter 2: Regulation of Human Pharmaceutical Safety: Routes to Human Use and Market

Chapter 3: Data Mining: Sources of Information for Consideration in Study and Program Design and in Safety Evaluation

Chapter 4: Screens in Safety and Hazard Assessment

Chapter 5: Formulations, Routes, and Dosage Regimens

Chapter 6: Nonclinical Manifestations, Mechanisms and Endpoints of Drug Toxicity

Chapter 7: Pilot Toxicity Testing in Drug Safety Evaluation: MTD and DRF

Chapter 8: Repeat Dose Toxicity Studies

Chapter 9: Genotoxicity

Chapter 10: QSAR Tools for Drug Safety

Chapter 11: Immunotoxicology in Drug Development

Chapter 12: Nonrodent Animal Studies

Chapter 13: Developmental and Reproductive Toxicity Testing

Chapter 14: Carcinogenicity Studies

Chapter 15: Histopathology in Nonclinical Pharmaceutical Safety Assessment

Chapter 16: Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment

Chapter 17: Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation

Chapter 18: Safety Pharmacology

Chapter 19: Special Concerns for the Preclinical Evaluation of Biotechnology Products

Chapter 20: Safety Assessment of Inhalant Drugs and Dermal Route Drugs

Chapter 21: Special Case Products: Imaging Agents

Chapter 22: Special Case Products: Drugs for the Treatment of Cancer

Chapter 23: Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile Toxicology)

Chapter 24: Imaging, Imaging Agents and Radiopharmaceuticals in Nonclinical Toxicology

Chapter 25: Occupational Toxicology in the Pharmaceutical Industry

Chapter 26: Strategy and Phasing for Non Clinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals

Chapter 27: The Application of In Vitro Techniques in Drug Safety Assessment

Chapter 28: Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond

Chapter 29: Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs)

Chapter 30: Statistics in Pharmaceutical Safety Assessment

Chapter 31: Combination Products: Drugs and Devices

Chapter 32: Qualification of Impurities, Degradants, Residual Solvents, Metals and Leachables in Pharmaceuticals

Chapter 33: Tissue, Cell and Gene Therapy

Appendix A: Selected Regulatory and Toxicological Acronyms

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

Appendix C: Notable Regulatory Internet Address

Appendix D: Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents

Appendix E: Common Vehicles for the Non Clinical Evaluation of Therapeutic Agents

Appendix F: Global Directory of Contract Toxicology Labs

"The stated goal of the third edition of Drug Safety Evaluation is to present an all-inclusive practical guide of how the safety of human drugs and biologics are evaluated. One just needs to peruse the table of contents to see that this book provides a comprehensive overview of human drug development as it applies to safety. The content encompasses the regulatory process for small molecules and biologics, and includes detailed descriptions of the toxicological tests that can be conducted and how the results are evaluated"... "Although the content is clearly meant for human pharma, this book will be useful to those involved in safety evaluations for veterinary drug development. The in-depth explanations of how data are evaluated from toxicity studies conducted for human drug development can be applied to animal drug development. The chapter on statistics in pharmaceutical safety assessment is particularly useful, with assumptions and limitations provided for each of the common statistical tests"...... "This comprehensive book on drug safety evaluation is a welcomed addition to my reference library" (Reviewed by Lesley C. Rausch-Derra, DVM, MS, Scout Bio Inc, Kansas City, Mo 15th June 2017)