The Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on bioanalytical method validation. This document defines the key elements to consider for validation of bioanalytical methods. the document was released in June 2011 and becomes effective in Feb. 2012.
Bioanalytical methods are used to support animal tox and clinical studies. The measurement of drug concentrations in biological matrices like blood, urine, saliva, etc., is an important part of drug development and supports regulatory filings. Therefore, characterization and validation of these methods is important.