ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

This document aims to recommend a basic framework for the preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies to products derived from characterised cells through the use of a variety of expression systems including bacteria, yeast, insect, plant, and mammalian cells.

Keywords: Non-clinical safety, biotechnology-derived pharmaceuticals, species selection, pharmacokinetics, toxicology

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