by Shayne C. Gad

Features:

• Presents international perspectives including the activities of the International Conference on Harmonization
• Explains how to integrate safety pharmacology evaluations into existing safety evaluation studies
• Covers the core battery of tests and supplemental testing procedures
• Discusses the principles of safety pharmacology study design and interpretation and their relevance to man
• Provides detailed coverage of this emerging discipline

Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery.

Giving you a head start in this emerging field, Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.

Contents

1. Background, History, and Concerns
2. Regulatory Requirements
3. Principles of Screening
4. Cardiovascular Systems
5. Central Nervous System
6. Respiratory System
7. Secondary Organ System
8. Gastrointestinal System
9. Immune System
10. Integration of Evaluations into Existing Safety Evaluation Study Designs

Appendices

Listing of Safety Pharmacology Laboratories
Acronyms

Index

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