Safety Assessment for Pharmaceuticals / Edition 1

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Overview

This practical, comprehensive resource provides the strategic tools necessary for designing an up-to-date safety assessment program, and gives you the practical tools you need to implement it. The book includes a comprehensive discussion of regulatory requirements, project management essentials, screens and phasing, along with highly specific advice on testing and assessment from acknowledged experts in toxicology. Every major test methodology is covered: * Acute, chronic, and subchronic toxicity studies. * Developmental and reproductive toxicity testing. * Pulmonary assessment. * Irritation and local tissue tolerance testing.

Current topics are included, from immunotoxicology, to nonrodent experiment design, to the future of In Vitro techniques. Avoiding dry mathematical and theoretical discussion in favor of practical guidance, this is the best reference available for understanding and performing safety assessments.

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Editorial Reviews

Booknews
Aimed specifically at the pharmaceutical and biotechnology industries, a practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated. Presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Individual chapters also address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.). Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780442001230
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 7/1/1994
  • Edition number: 1
  • Pages: 512
  • Product dimensions: 6.39 (w) x 9.34 (h) x 1.46 (d)

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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