Guidelines from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are applied in the validation of bioanalytical methods for pharmacokinetic and bioequivalence studies as well as many pharmacodynamic parameters. They define the requirements with respect to response function, precision, accuracy and stability. As an organization following Good Clinical Laboratory Pratice, we follow these guidelines in our validation studies for bioanalytical methods.
The most recent versions of these guidelines can be downloaded here.
- EMA Guideline Analytical Method Validation 2011 (158.77 KB)
- FDA Bioanalytical Validation Guideline 2001 (63.28 KB)
EMA Reflection Paper for Laboratories involved in Clinical Studies
The European Medicines Agency (EMA) has issued a reflection paper for laboratories that contribute to clinical studies. It details tighter requirements for the conduct of laboratory analyses for clinical studies and for the quality systems of the laboratories involved. Interestingly, standard clinical chemistry and hematology are also subject to these requirements to the same extent as sophisticated biomarker assays.
The reflection paper can be downloaded here.
- EMA Reflection Paper GCLP 2012 (166.61 KB)