Gad Drug Safety Evaluation

3. Auflage 2016
ISBN: 978-1-119-09740-2
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, Band 1, 918 Seiten, E-Book

Reihe: Pharmaceutical Development

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
* Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development
* Explains scientific and philosophical bases for evaluation of specific concerns - including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity
* Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars
* Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation
* Adds almost 20% new and thoroughly updates existing content from the last edition

Autoren/Hrsg.

Gad, Shayne Cox

Inhaltsverzeichnis

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

Über Autor(innen)

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.