Providing detailed coverage of an emerging discipline within the pharmaceutical industry, Safety Pharmacology in Pharmaceutical Development and Approval lays out exactly 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. The author addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.
