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Safety Assessment for Pharmaceuticals
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More About This Title Safety Assessment for Pharmaceuticals

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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.

  • English

English

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. Gáler).

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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