Zdrowie i gospodarka · 07/08/2000

International Conference on Harmonisation; Draft Guidance on Safety Pharmacology Studies for Human Pharmaceuticals; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "S7 Safety Pharmacology Studies for Human Pharmaceuticals." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes general principles and recommendations for safety pharmacology evaluations. The draft guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse reactions to pharmaceuticals and to avoid unnecessary use of animals and other resources.