 Drug Safety Evaluation
ISBN: 978-0-471-40727-0
Hardcover
1024 pages
April 2002
US $212.50
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Preface.
About the Author.
Strategy and Phasing for Drug 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 Drug 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.
Formulations, Routes, and Dosage 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.
Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond.
Postmarketing Safety Evaluation: Monitoring Assessing and Reporting of Adverse Drug Response (ADRs).
Statistics in Pharmaceutical Safety Assessment.
Appendix A: Selected Relatory 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 Clinical Evaluation of Therapeutic Agents.
Index.
About the Author.
Strategy and Phasing for Drug 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 Drug 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.
Formulations, Routes, and Dosage 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.
Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond.
Postmarketing Safety Evaluation: Monitoring Assessing and Reporting of Adverse Drug Response (ADRs).
Statistics in Pharmaceutical Safety Assessment.
Appendix A: Selected Relatory 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 Clinical Evaluation of Therapeutic Agents.
Index.
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