QualityHome Quality FDA Guidance for Industry: Bioanalytical Method Validation, May 2018PDF (362.06 KB)Download Read More EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012PDF (104.00 KB)Download Read More EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010PDF (227.06 KB)Download Read More EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002PDF (304.62 KB)Download Read More FDA Guideline on validation of bioanalytical methods, May 2001PDF (49.98 KB)Download Read More ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsPDF (178.40 KB)Download Read More
