Drug safety evaluation [Elektronisk resurs] / Shayne Cox Gad.

• Front Matter -- Drug Development Process and Global Pharmaceutical Marketplace -- Regulation of Human Pharmaceutical Safety -- Prior Art and Its Use in Safety Assessment Process -- Screens in Safety and Hazard Assessment -- Formulations, Routes, and Dosage Design -- Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation -- Genotoxicity -- Repeat-Dose Toxicity Studies -- Immunotoxicology in Drug Development -- Nonrodent Animal Studies -- Developmental and Reproductive Toxicity Testing -- Carcinogenicity Studies -- Histopathology in Nonclinical Pharmaceutical Safety Assessment -- Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment -- Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation -- Safety Pharmacology -- Special Concerns for Preclinical Evaluation of Biotechnology Products -- Safety Assessment of Inhalant and Dermal Route Drugs -- Special-Case Products: Imaging Agents and Oncology Drugs -- Occupational Toxicology in Pharmaceutical Industry -- Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals -- Application of In Vitro Techniques in Drug Safety Assessment -- Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond -- Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses -- Statistics in Pharmaceutical Safety Assessment -- Combination Products: Drugs and Devices -- Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals -- Appendix A: Selected Regulatory 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 -- Appendix E: Common Vehicles for Nonclinical Evaluation of Therapeutic Agents -- Appendix F: Global Directory of Contract Toxicology Laboratories -- Index.

Ämnesord

Drugs  -- Toxicology. (LCSH)

Drugs  -- Testing. (LCSH)

Drug Evaluation, Preclinical.  (MeSH)

Drug Evaluation.  (MeSH)

Product Surveillance, Postmarketing.  (MeSH)

Arzneimittelsicherheit.  (swd)

Genre

Electronic books. 

Klassifikation

RA1238 (LCC)

QV 771 (NLM)

615/.19 (DDC)

Pmca (kssb/8 (machine generated))