ICH - Harmonised Tripartite Guideline

Q2(R1) Validation of Analytical Procedures: Text and Methodology

S6 (R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals


EMA Guidelines

Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, EMA/CHMP/BMWP/86289/2010, December 2012

Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), EMA/CHMP/BWP/247713/2012, November 2012

EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010

EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, EMEA/CHMP/BMWP/14327/2006, April 2008

EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant erythropoietins, EMEA/CHMP/BMWP/31329/2005, June 2006

EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002


EMA Concept/Reflection Papers

EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012

EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, EMEA/CHMP/BMWP/114720/2009, June 2009

EMA Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods, EMEA/CHMP/EWP/531305/2008, March 2009


FDA - Guidance for Industry

Bioanalytical Method Validation, September 2013

Immuogenicity Assessment for Therapeutic Protein Products, February 2013

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2012

Assay Development for Immunogenicity Testing of Therapeutic Proteins, Dec 2009

Bioanalytical Method Validation, May 2001