
FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology.
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FDA has updated a 2001 guidance on bioanalytical method validation because of advances in bioanalytical technology and science.
The guidance applies to gas chromatography (GC); high-pressure liquid chromatography (LC); combined GC and LC mass spectrometric (MS) procedures, such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS; and ligand binding assays (LBAs), and immunological and microbiological procedures that are performed for the quantitative determination of drugs and/or metabolites, and therapeutic proteins in biological matrices, such as blood, serum, plasma, urine, tissue, and skin.
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