Bioanalytical method validation

This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability and bioequivalence studies requiring pharmacokinetic evaluation. This paper provides general recommendations for bioanalytical method validation that can be adjusted or modified depending on the analytical method used.

The information generally applies to bioanalytical procedures such as gas chromatography (GC), high-pressure liquid chromatography (LC), combined GC and LC mass spectrometric procedures such as LC-MS, LC-MS-MS, GC-MS and GC-MS-MS performed for the quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma or urine. It also applies to other bioanalytical methods, such as immunological and microbiological procedures, and to other biological matrices, such as tissue and skin samples.

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