EMA publishes "Draft Guideline on Validation of bioanalytical Methods"

On 8th December, EMA published a new draft guideline on validation of bioanalytical methods. This guideline is open for comments until 31 May 2010.

For medicinal product development of products with new active substances as well as generic products, the measurement of drug concentration in biological matrices is vitally important. Toxicokinteic, pharmacokinetic and bioequivalence studies will give necessary data for the assessment of safety and efficacy of a medicinal drug or product.  Furthermore such data may be required for new applications or variations to authorised drug products.

This draft 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. Furthermore, specific aspects of the bioanalytical method itself will be addressed and the guideline will describe when partial validation or cross validation may represent an appropriate alternative approach to the complete validation.

Special techniques such as radio-labelled analysis methods using 14C labelled drugs are not covered in this guideline, but even in such cases efforts should be made to apply to the principles of this guideline.

More information can be found here.

The "6th Bio Production Forum" in Geneva, Switzerland, from 15 -17 June 2010 will provide information about development, transfer and authorisation of biopharmaceutical products.

Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)

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