«GUIDELINE ON VALIDATION OF BIOANALYTICAL METHODS»

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.

http://www.ema.europa.eu/pdfs/human/ewp/19221709en.pdf

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