S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Regulatory Resource: S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document covers the pre-clinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

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