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.
"PREFACE xxix ABOUT THE AUTHORS xxxi 1 The Drug Development Process and The Global Pharmaceutical Marketplace 1 2 Regulation of Human Pharmaceutical Safety: Routes To Human Use and Market 19 3 Data Mining: Sources of Information For Consideration In Study And Program Design and In Safety Evaluation 67 4 Electronic Records, Reporting, and Submission: eCTD and Send 75 5 Screens in Safety and Hazard Assessment 83 6 Formulations, Routes, and Dosage Regimens 95 7 Mechanisms And End Points Of Drug Toxicity 131 8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF 143 9 Repeat-Dose Toxicity Studies 173 10 Genotoxicity 183 11 QSAR Tools For Drug Safety 223 12 Toxicogenomics 241 13 Immunotoxicology In Drug Development 247 14 Nonrodent Animal Studies 293 15 Developmental And Reproductive Toxicity Testing 331 16 Carcinogenicity Studies 363 17 Histopathology and Clinical Pathology In Nonclinical Pharmaceutical Safety Assessment 395 18 Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment 403 19 Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation 425 20 Safety Pharmacology 457 21 Special Concerns For The Preclinical Evaluation Of Biotechnology Products 477 22 Safety Assessment of Inhalant Drugs And Dermal Route Drugs 507 23 Special Case Products: Imaging Agents 529 24 Special Case Products: Drugs For Treatment Of Cancer 535 25 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile And Pediatric Toxicology) 543 26 Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology 551 27 Occupational Toxicology In The Pharmaceutical Industry 571 28 Strategy and Phasing For Nonclinical Drug Safety EvaluationIn The Discovery and Development of Pharmaceuticals 585 29 The Application of In Vitro Techniques In Drug Safety Assessment 603 30 Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond 635 31 Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting of Adverse Drug Responses (ADRs) 683 32 Statistics In Pharmaceutical Safety Assessment 707 33 Combination Products: Drugs and Devices 767 34 Qualification Of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals 777 35 Tissue, Cell, and Gene Therapy 789 36 Adverse Outcome Pathways in Drug Safety Assessment 801 Appendix A: Selected Regulatory and Toxicological Acronyms 805 Appendix B: Definition Of Terms And Lexicon of ""Clinical"" Observations in Nonclinical (Animal) Studies 807 Appendix C: Notable Regulatory Internet Addresses 811 Appendix D: Glossary Of Terms Used in The Clinical Evaluation of Therapeutic Agents 817 Appendix E: Common Vehicles For The Nonclinical Evaluation of Therapeutic Agents 821 Appendix F: Global Directory of Contract Toxicology Labs 919 INDEX 945"
Shayne Cox Gad, PhD, DABT is the Principal of Gad Consulting Services. He has more than 47 years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He has successfully file 138 INDs and authored and edited 52 books, as well as numerous papers, presentations, and other publications. Dexter W. Sullivan, Jr., MS, DABT is Senior Toxicologist at Gad Consulting Services.
