Best practices in a tiered approach to metabolite quantification: Views and recommendations of the European Bioanalysis Forum

Bioanalysis

Volumn 2, Issue 7, 2010, Pages 1185-1194

  Timmerman, Philip ^a   Anders Kall, Morten ^a   Gordon, Ben ^a   Laakso, Sirpa ^a   Freisleben, Achim ^a   Hucker, Richard ^a  

^a JOHNSON AND JOHNSON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; DRUG;

ARTICLE; CONCENTRATION (PARAMETERS); DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERDISCIPLINARY COMMUNICATION; INTERNATIONAL COOPERATION; NONHUMAN; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; SCREENING TEST; VALIDATION PROCESS; ANIMAL; CLINICAL TRIAL (TOPIC); DRUG TOXICITY; GOVERNMENT REGULATION; METABOLISM; REPRODUCIBILITY; TOXICITY TESTING;

ANIMALS; CLINICAL TRIALS AS TOPIC; DRUG TOXICITY; EUROPE; GOVERNMENT REGULATION; HUMANS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; TOXICITY TESTS;

EID: 79951896481     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.90     Document Type: Article

References (11)

1. Baillie T, Cayen MN, Fouda H et al. Drug metabolites in safety testing. Toxicol. Appl. Pharmacol. 182, 188-196 (2002).
2. Smith D, Obach RS. Seeing through the MIST: abundance versus percentage. Commentary on metabolites in safety testing. Drug Metab. Dispos. 33, 1409-1417 (2005). (Pubitemid 41323986)
3. Robison T, Jacobs A. Metabolites in safety testing. Bioanalysis 1(7), 1193-1200 (2009).
4. US FDA Guidance for Industry, Safety Testing of Drug Metabolites. US Department of Health and Human Services Food and Drug Administration. Center for drug evaluation and research (CDER).Pharmacology Toxicology (2008).
5. CPMP/ICH/286/95 - ICH Topic M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2009).
6. Guidance for Industry Bioanalytical Method Validation US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) (2001).
7. Viswanathan C, Bansal S, Booth B et al. Workshop/Conference Report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E42 (2007). (Pubitemid 46296546)
8. Leclercq L Cuyckens F, de Vries R et al. Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem. Res. Toxicol. 22(2), 280-293 (2009).
9. Abbott R, Brudny-Kloeppel M. Conference report from 1st open symposium - burning issues in bioanalysis. Bioanalysis 1(2), 273-276 (2009).
10. Lee J, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006). (Pubitemid 43237862)
11. Abbott R. Conference report from 2nd Open Symposium - the broadening scope of validation. Bioanalysis 2(4), 703-708 (2010).