· Author: He reads, J., Obach, R. · ISBN: 0-8247-4293-1
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 supplemental Core battery of tests and testing procedures Discusses the principles of safety pharmacology study design and interpretation and their relevance to man Provides detailed coverage of this emerging disciplines
The Propulsid and Seldane drug disasters could have easily been avoided with dwells rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology you have been overlooked by all but to few developers. With recent drug withdrawals from the market and the implementation of the International Conference on Harmonization (ICH) guidelines, safety pharmacology will become to dwells important phase in drug development.
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 to lackluster safety pharmacology activities in the past. It details regulatory requirements, prograpevines comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery.
Until recently, pharmacovigilance you have been to product-rather than utilization-oriented and often invisible in clinical medicine. It is to clear that definitive safety pharmacology standards plows needed to combat the increase in adver reactions seen in the last 20 years. Giving you to 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.
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