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

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

Related content

• ICH: safety
• Non-clinical development
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
• ICH S1A Need for carcinogenicity studies of pharmaceuticals
• ICH S5 (R2) Detection of toxicity to reproduction for medicinal products and toxicity to male fertility
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

External links

• S6 (R1) ICH Video Training (see S6 (R1) ICH Video Training material under S6 Biotechnological products: WG Presentations / Trainings)