EMA Guideline on bioanalytical Method Validation adopted

On June 21, the CHMP adopted the Guideline on bioanalytical method validation. This guideline defines key elements necessary for the validation of bioanalytical methods.

An important part of  the development of pharmaceutical products is the measurement  of drug concentrations in biological matrices, e.g. plasma, blood and urine. This data may be important and useful to support applications for new substances and generics. Furthermore they may be required for variations to authorised drug products. Quantitative concentration data, generated by bioanalytical methods, are used for pharmacokinetic and toxicokinetic parameter determinations.The results of animal toxicokinetic studies and of clinical trials, including bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product.

This guideline provides recommendations for the validation of bioanalytical methods applied to measure drug concentrations in biological matrices obtained in animal toxicokinetic studies and all phases of clinical trials. As ligand binding assays differ substantially from chromatographic analytical methods, separate validation recommendations for ligand binding assays are provided. In addition, specific aspects for the analysis of study samples will be addressed.

Furthermore, this guideline will describe when partial validation or cross validation should be carried out in addition to the full validation of an analytical method.

Methods used for determining quantitative concentrations of biomarkers used in assessing pharmacodynamic endpoints are out of the scope of this guideline.

The complete guideline will become effective on 1 February 2012.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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