Guidance Home 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 2012 PDF (135.05 KB) Download Find Out More EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010 PDF (227.06 KB) Download Find Out More EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009 PDF (32.47 KB) Download Find Out More EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009 PDF (36.03 KB) Download Find Out More EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007 PDF (162.06 KB) Download Find Out More EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005 PDF (80.49 KB) Download Find Out More EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002 PDF (304.62 KB) Download Find Out More FDA Guideline on validation of bioanalytical methods, May 2001 PDF (49.98 KB) Download Find Out More ICH Q2B Guideline Validation of Analytical Procedures Methodology PDF (34.30 KB) Download Find Out More Previous 1 2 3 Next
