Safety assessment for pharmaceuticals

Bibliographic Information

Safety assessment for pharmaceuticals

Shayne C. Gad

J. Wiley, c1995

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Note

Includes bibliographical references and index

Description and Table of Contents

Description

This is a practical guide to safety assessment in the pharmaceutical industry, written by experienced professionals currently active in the field.

Table of Contents

  • Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals - S. Gad
  • Information Sources: Building and Maintaining Data Files - D. Larson, et al.
  • Screens in Safety and Hazard Assessments - S. Gad
  • Acute Toxicity Testing in Drug Safety Evaluation - C. Chengelis
  • Subchronic and Chronic Toxicity Studies - S. Gad
  • Developmental and Reporductive Toxicity Testing - R. Clark
  • Carcinogenicity Studies - L. DePass
  • Safety Assessment of Inhalant Drugs - B. Leong
  • Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment - S. Gad
  • Routes, Formulations, and Dose Designs - S. Gad
  • Occupational Toxicology in the Pharmaceutical Industry - D. Galer
  • Immunotoxicology in Pharmaceutical Development - P. Guzzie
  • Special Case: Nonrodent Studies - G. Haggerty
  • The Application of In Vitro Techniques in Drug Safety Assessment - P. Williams, et al.
  • Appendix
  • Index.

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