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
Current effective version - Revision 1
ICH: S6(R1): Preclinical safety evaluation of biotechnology - derived pharmaceuticals - Step 5