Drug Safety EvaluationJohn Wiley & Sons, 2003 M09 5 - 1024 pages 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:
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Contents
About the Author | x |
Chapter 1 Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals | 1 |
Chapter 2 Regulation of Human Pharmaceutical Safety | 30 |
Chapter 3 Information Sources Building and Maintaining Data Files | 99 |
Chapter 4 Screens in Safety and Hazard Assessment | 112 |
Chapter 5 Acute Toxicity Testing in Drug Safety Evaluation | 130 |
Chapter 6 Genotoxicity | 176 |
Chapter 7 Subchronic and Chronic Toxicity Studies | 237 |
Chapter 15 Immunotoxicology in Pharmaceutical Development | 527 |
Chapter 16 Nonrodent Animal Studies | 595 |
Chapter 17 The Applicatioin of In Vitro Techniques in Drug Safety Assessment | 634 |
Chapter 18 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation | 691 |
Chapter 19 Safety Pharmacology | 737 |
Chapter 20 Evaluation of Human Tolerance and Safety in Clinical Trials Phase I and Beyond | 764 |
Chapter 21 Postmarketing Safety Evaluation Monitoring Assessing and Reporting of Adverse Drug Responses ADRs | 831 |
Chapter 22 Statistics in Pharmaceutical Safety Assessment | 862 |
Chapter 8 Developmental and Reproductive Toxicity Testing | 258 |
Chapter 9 Carcinogenicity Studies | 297 |
Chapter 10 Safety Assessment of Inhalant Drugs | 335 |
Chapter 11 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment | 367 |
Chapter 12 Special Concerns for the Preclinical Evaluation of Biotechnology Products | 404 |
Chapter 13 Formulations Routes and Dosage Designs | 442 |
Chapter 14 Occupational Toxicology in the Pharmaceutical Industry | 505 |
Appendix A Selected Regulatory and Toxicological Acronyms | 971 |
Appendix B Definition of Terms and Lexicon of Clinical Observations in Nonclinical Animal Studies | 975 |
Appendix C Notable Regulatory Internet Addresses | 979 |
Appendix D Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents | 990 |
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Common terms and phrases
absorption activity administration adverse adverse drug reactions aerosols agents analysis and=or antibody antigen assay biological blood body weight carcinogenicity cells chemical chromosome clinical trials compounds concentration culture dermal detect determine developmental toxicity disease dosage dose drug effects example excipients exposure factors function gene guidelines hepatocytes human immune immunotoxicity increase inhalation injection irritation kgÀ1 laboratory lethality liver macrophages measure metabolism metabolites methods mice molecules monoclonal antibodies mutagenicity mutation nonrodent number of animals observed oral organ parameters patients pharmaceutical pharmacokinetic Pharmacol pharmacological pharmacology Phase potential preclinical protein protocol rabbit rats reactions regulations regulatory renal response rodent route route of administration safety assessment sample screen sensitivity skin specific statistical Table techniques teratogenicity Teratology test article therapeutic tissue toxicity toxicity studies toxicity testing Toxicol toxicology treatment tumor variables vitro vivo xenobiotics