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S7A - PharmaFacts
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Guidances - ICH Guidances

S7A: Safety Pharmacology Studies for Human Pharmaceuticals:

The ICH guideline reached Step 4 of the ICH process in November 2000. This document addresses the definition, objectives and scope of safety pharmacology studies. It also addresses which studies are needed before initiation of Phase 1 clinical studies as well as information needed for marketing.