FDA Reissues Bioanalytical Method Validation Guidance - - BioPharm International

ADVERTISEMENT

FDA Reissues Bioanalytical Method Validation Guidance


RELATED ARTICLES

More in GMPs/Validation

FDA has updated a 2001 guidance on bioanalytical method validation because of advances in bioanalytical technology and science. Guidance for Industry, Bioanalytical Method Validation, Draft Guidance provides general recommendations for bioanalytical method validation that may be modified depending on the type of method used. The draft offers guidance on the development of bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements.

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.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Yale and Gilead Extend Sequencing Initiative
October 28, 2014
Contract Research and Manufacturing Organization Paragon Bioservices Raises $13 Million
October 28, 2014
Novartis Sells Influenza Vaccine Business to CSL for $275 Million
October 27, 2014
Author Guidelines

Click here