Drug Safety Evaluation Pharmaceutical Development Series 4th Edition by Shayne Cox Gad, Dexter Sullivan ISBN 978-1119755852 1119755859

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Product details: 

ISBN 10: 1119755859

ISBN 13: 978-1119755852

Author: Shayne Cox Gad, Dexter W. Sullivan Jr.  

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: 

1. The Drug Development Process and The Global Pharmaceutical Marketplace

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

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

4. Electronic Records, Reporting, and Submission: eCTD and SEND

5. Screens in Safety and Hazard Assessment

6. Formulations, Routes, and Dosage Regimens

7. Mechanisms and End Points of Drug Toxicity

8. Pilot Toxicity Testing in Drug Safety Evaluation: MTD and DRF

9. Repeat-Dose Toxicity Studies

10. Genotoxicity

11. QSAR Tools for Drug Safety

12. Toxicogenomics

13. Immunotoxicology in Drug Development

14. Nonrodent Animal Studies

15. Developmental and Reproductive Toxicity Testing

16. Carcinogenicity Studies

17. Histopathology and Clinical Pathology in Nonclinical Pharmaceutical Safety Assessment

18. Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment

19. Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation

20. Safety Pharmacology

21. Special Concerns for the Preclinical Evaluation of Biotechnology Products

22. Safety Assessment of Inhalant Drugs and Dermal Route Drugs

23. Special Case Products: Imaging Agents

24. Special Case Products: Drugs for Treatment of Cancer

25. Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile and Pediatric Toxicology)

26. Use of Imaging, Imaging Agents, and Radiopharmaceuticals in Nonclinical Toxicology

27. Occupational Toxicology in the Pharmaceutical Industry

28. Strategy and Phasing for Nonclinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals

29. The Application of In Vitro Techniques in Drug Safety Assessment

30. Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond

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

32. Statistics in Pharmaceutical Safety Assessment

33. Combination Products: Drugs and Devices

34. Qualification of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals

35. Tissue, Cell, and Gene Therapy

36. Adverse Outcome Pathways in Drug Safety Assessment

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Tags: Shayne Cox Gad, Dexter Sullivan, Drug Safety, Evaluation Pharmaceutical