BEBAC  Ing. Helmut Schütz


Draft Guideline on Validation of Bioanalytical Methods

On 08 Dec 2009 the EMA published the drafted guideline EMEA/CHMP/EWP/192217/2009 for a six-month public consultation period (i.e., until 31 May 2009).

This guideline defines key elements and provides recommendations for the validation of bioanalytical methods. The guideline focuses on the validation of the analytical methods used for pharmacokinetic sample analysis. In addition, guidance will be provided with regard to the actual analysis of study samples.

  1. INTRODUCTION (background)
    Measurement of drug concentrations in biological matrices is an important aspect of medicinal product development for those products containing new active substances as well as for line extensions and generic products. Such data may be required to support new applications as well as variations to authorised drug products. The results of toxicokinetic, pharmacokinetic and bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product. It is therefore paramount that the applied bioanalytical methods used are well characterised, fully validated and documented to a satisfactory standard in order to yield reliable results.
    Acceptance criteria wider than those defined in this guideline may need to be used in special situations, such as analysis of complex matrices (e.g. solid tissues), when usual acceptance criteria cannot be met. This should be justified and prospectively defined.
  2. SCOPE
    This guideline provides requirements for the validation of bioanalytical methods.
    In addition, specific aspects of the bioanalytical method itself will be addressed, e.g. the actual analysis of samples from toxicokinetic studies and clinical trials.
    Furthermore, this guideline will describe when partial validation or cross validation may represent an appropriate alternative approach to the complete validation of an analytical method.
    Some special techniques such as radio-labelled analysis methods using 14C labelled drugs, are not covered here, but even in such cases efforts should be made to apply to the principles of this guideline.


The final guideline (EMEA/CHMP/EWP/192217/2009) was adopted by the CHMP on 21  July 2011 and is effective with 1 February 2012.