Results of pharmacokinetic studies are an important background to make critical decisions supporting therapeutic efficacy of drugs and safety of patients. Therefore, reliability of bioanalytical methods must be proven by detailed validation. Novel European Medicines Agency (EMA) guideline [1] describes mostly known and widely applied requirements, but also introduces some novel recommendations, e.g. incurred sample reanalysis.

EMA guideline is dedicated to toxicokinetic and pharmacokinetic studies in all phases of clinical trials and specifies requirements for determination of both macromolecules and small molecular weight drugs. In the latter case, liquid chromatography coupled to mass spectrometry (LC/MS) is a method of choice. Specific recommendations concerning LC/MS-based bioanalytical methods include matrix effect evaluation, internal standard selection (preferably stable isotope-labeled) and assessment of back-conversion of analyte to its metabolite in ionization source.

Currently, the guideline is the most complete and up-to-date document on bioanalytical issues. EMA and U.S. Food and Drug Administration (FDA) [2] requirements in this field are compliant to a large extent, which is very important for pharmaceutical industry.

[1] Guideline on bioanalytical method validation. European Medicines Agency (EMEA/CHMP/EWP/192217/2009). London, 21 July 2011.

[2] Guidance for Industry. Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation
and Research (CDER). Center for Veterinary Medicine (CVM). May 2001.

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