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Drug safety evaluation / Shayne Cox Gad, Dexter W. Sullivan, Jr.

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"This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. This book helps readers understand how the safety of these products are evaluated f...

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Bibliographic Details
Online Access: Full Text (via Knovel)
Main Authors: Gad, Shayne C., 1948- (Author), Sullivan, Dexter W., Jr (Author)
Format: Electronic eBook
Language:English
Published: Hoboken, NJ : John Wiley & Sons, Inc., 2023.
Edition:Fourth edition.
Subjects:
Drugs > Toxicology.
Drugs > Testing.
Pharmacovigilance.
Drugs > Side effects > Reporting.
Drug monitoring.
Table of Contents:
  • The Drug Development Process and the Global Pharmaceutical Marketplace
  • Regulation of Human Pharmaceutical Safety : Routes to Human Use and Market
  • Data Mining : Sources of Information for Consideration in Study and Program Design and in Safety Evaluation
  • Electronic Records, Reporting, and Submission : eCTD and Send
  • Screens in Safety and Hazard Assessment
  • Formulations, Routes, and Dosage Regimens
  • Mechanisms and End Points of Drug Toxicity
  • Pilot Toxicity Testing in Drug Safety Evaluation : MTD and DRF
  • Repeat­Dose Toxicity Studies
  • Genotoxicity
  • QSAR Tools for Drug Safety
  • Toxicogenomics
  • Immunotoxicology in Drug Development
  • Nonrodent Animal Studies
  • Developmental and Reproductive Toxicity Testing
  • Carcinogenicity Studies
  • Histopathology and Clinical Pathology 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 the Preclinical Evaluation of Biotechnology Products
  • Safety Assessment of Inhalant Drugs and Dermal Route Drugs
  • Special Case Products : Imaging Agents
  • Special Case Products : Drugs for Treatment of Cancer
  • Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile and Pediatric Toxicology)
  • Use of Imaging, Imaging Agents, and Radiopharmaceuticals in Nonclinical Toxicology
  • Occupational Toxicology in the Pharmaceutical Industry
  • Strategy and Phasing for Nonclinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals
  • The Application of In Vitro Techniques in Drug Safety Assessment
  • Evaluation of Human Tolerance and Safety in Clinical Trials : Phase I and Beyond
  • Postmarketing Safety Evaluation : Monitoring, Assessing, and Reporting of Adverse Drug Responses (Adrs)
  • Statistics in Pharmaceutical Safety Assessment
  • Combination Products : Drugs and Devices
  • Qualification of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals
  • Tissue, Cell, and Gene Therapy
  • Adverse Outcome Pathways in Drug Safety Assessment
  • 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 the Clinical Evaluation of Therapeutic Agents
  • Appendix E. Common Vehicles for the Nonclinical Evaluation of Therapeutic Agents
  • Appendix F. Global Directory of Contract Toxicology Labs.

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