GuidanceHome Scientific Expertise Scientific Insights Guidance Page 2 EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012PDF (135.05 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 Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009PDF (32.47 KB)Download Read More EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009PDF (36.03 KB)Download Read More EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007PDF (162.06 KB)Download Read More EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005PDF (80.49 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 Q2B Guideline Validation of Analytical Procedures MethodologyPDF (34.30 KB)Download Read More Previous 1 2 3 Next