S7A Safety Pharmacology Studies for Human Pharmaceuticals

Issue Date: July 13, 2001
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Safety
Status: Final

S7A Safety Pharmacology Studies for Human Pharmaceuticals

This guidance was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.

Download the Guidance Document

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