A comprehensive safety guide to all aspects of the drug development process!
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated.
Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions.
Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems.
Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:
- Acute toxicity testing in pharmaceutical safety evaluation
- Genotoxicity
- Safety assessment of inhalant drugs
- Immunotoxicology in pharmaceutical development
- Large animal studies
- Evaluation of human tolerance and safety in clinical trials
Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Contents
- Strategy and Phasing for Preclinical Safety Evaluation in the Discovery and Development of Pharmaceuticals
- Regulation of Human Pharmaceutical Safety
- Information Sources: Building and Maintaining Data Files
- Screens in Safety and Hazard Assessments
- Acute Toxicity Testing in Pharmaceutical Safety Evaluation
- Genotoxicity
- Subchronic and Chronic Toxicity Studies
- Developmental and Reproductive Toxicity Testing
- Carcinogenicity Studies
- Safety Assessment of Inhalant Drugs
- Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
- Special Concerns for the Preclinical Evaluation of Biotechnology Products
- Routes, Formulations, and Dose Designs
- Occupational Toxicology in the Pharmaceutical Industry
- Immunotoxicology in Pharmaceutical Development
- Large Animal Studies
- The Application of In Vitro Techniques in Drug Safety Assessment
- Pharmacokinetics/Toxicokinetics in Drug Safety Evaluation
- Safety Pharmacology Studies
- Evaluation of Human Tolerance and Safety in Clinical Trials
- Postmarketing Safety Evaluation: Monitoring of Adverse Drug Response (ADRs)
- Statistics in Pharmaceutical Safety Assessment
Appendices
- Chronology of Drug Safety Evaluation Failures
- Definition of Terms and Lexicon of Clinical Observations
- Common Acronyms in Pharmaceutical Safety Evaluation and Toxicology
- Websites of Interest
Index
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