Drug Safety Evaluation

Shayne Cox Gad, Dexter W. Sullivan

• Publisher: Wiley
• Year: 2022
• ISBN:
  9781119755869
• Edition: 4
• Topic: Medicine
• Subtopic: Pharmacology

Drug Safety Evluation

Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics

This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market.

Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought.

The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters.

Specific sample topics covered in Drug Safety Evaluation include:

• The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety
• Sources of information for consideration in study and program design and in safety evaluation
• Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens
• Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity
• Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing
• An appendix which provides an up to date guide to CROs for conducting studies

Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Table of contents

• Cover
• Title Page
• Copyright Page
• Acknowledgment
• Contents
• Preface
• About the Authors
• 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 Electronic Records, Reporting, and Submission: eCTD and Send
• Chapter 5 Screens in Safety and Hazard Assessment
• Chapter 6 Formulations, Routes, and Dosage Regimens
• Chapter 7 Mechanisms And End Points Of Drug Toxicity
• Chapter 8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF
• Chapter 9 Repeat­Dose Toxicity Studies
• Chapter 10 Genotoxicity
• Chapter 11 QSAR Tools For Drug Safety
• Chapter 12 Toxicogenomics
• Chapter 13 Immunotoxicology In Drug Development
• Chapter 14 Nonrodent Animal Studies
• Chapter 15 Developmental And Reproductive Toxicity Testing
• Chapter 16 Carcinogenicity Studies
• Chapter 17 Histopathology and Clinical Pathology In Nonclinical Pharmaceutical Safety Assessment
• Chapter 18 Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment
• Chapter 19 Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation
• Chapter 20 Safety Pharmacology
• Chapter 21 Special Concerns For The Preclinical Evaluation Of Biotechnology Products
• Chapter 22 Safety Assessment of Inhalant Drugs And Dermal Route Drugs
• Chapter 23 Special Case Products: Imaging Agents
• Chapter 24 Special Case Products: Drugs For Treatment Of Cancer
• Chapter 25 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile And Pediatric Toxicology)
• Chapter 26 Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology
• Chapter 27 Occupational Toxicology In The Pharmaceutical Industry
• Chapter 28 Strategy and Phasing For Nonclinical Drug Safety Evaluation In The Discovery and Development of Pharmaceuticals
• Chapter 29 The Application of In Vitro Techniques In Drug Safety Assessment
• Chapter 30 Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond
• Chapter 31 Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting of Adverse Drug Responses (ADRs)
• Chapter 32 Statistics In Pharmaceutical Safety Assessment
• Chapter 33 Combination Products: Drugs and Devices
• Chapter 34 Qualification Of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals
• Chapter 35 Tissue, Cell, and Gene Therapy
• Chapter 36 Adverse Outcome Pathways in Drug Safety Assessment
• 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 Addresses
• Appendix D: Glossary Of Terms Used in The Clinical Evaluation of Therapeutic Agents
• Appendix E: Common Vehicles For The Nonclinical Evaluation of Therapeutic Agents
• Appendix F: Global Directory of Contract Toxicology Labs
• Index
• EULA