Drugmakers Get Tips on Biotech Drug Dose Selection in Guidance Addendum

Drugmakers will see more explanation of the proper nonclinical steps to support safety of clinical trials and marketing applications for biotech drugs in an International Conference on Harmonisation (ICH) guidance addendum, just issued by the FDA. The addendum complements, clarifies and updates topics in ICH S6, “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” Biotech drugs include protein therapeutic, diagnostic and prophylactic products derived from cell-culture systems such as bacteria and yeast, and organisms produced by rDNA technology.
Clinical Trials Advisor