Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO

Bioanalysis

Volumn 3, Issue 4, 2011, Pages 449-465

  Meng, Min ^a   Reuschel, Scott ^a   Bennett, Patrick ^b  

^a Northwest Toxicology Inc   (United States)

^b Thermo Fisher Scientific   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOINFORMATICS; BIOTECHNOLOGICAL PROCEDURES; DOCUMENTATION; GOOD LABORATORY PRACTICE; IONIZATION; MATHEMATICAL ANALYSIS; PRECIPITATION; PROCESS OPTIMIZATION; QUALITY CONTROL; REVIEW; TANDEM MASS SPECTROMETRY;

ANIMALS; ARTIFACTS; BLOOD CHEMICAL ANALYSIS; CHEMISTRY TECHNIQUES, ANALYTICAL; CHROMATOGRAPHY, LIQUID; HUMANS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; RESEARCH REPORT; TANDEM MASS SPECTROMETRY;

EID: 79952016469     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.212     Document Type: Review

References (7)

1. Shah VP, Midha KK, Dighe S et al. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. Pharm. Res. 9, 588-592 (1992).
2. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for the Industry: Bioanalytical Method Validation. Rockville, MD, USA, May 2001.
3. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9, E30-E42 (2007). (Pubitemid 46296546)
4. Rocci ML, Devanarayan V, Haughey DB et al. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J. 9(3), E336-E343 (2007). (Pubitemid 351816757)
5. Fast DM, Kelley M, Viswanathan C et al. AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples-implications of crystal city recommendations. AAPS J. 11(2), 238-241 (2009).
6. Timmerman P, Luedtke S, Amsterdam PV et al. Incurred sample reproducibility, views and recommendations by the European Bioanalysis Forum. Bioanalysis 1(6), 1049-1056 (2009).
7. Jemal M, Zheng O, Xia YQ. Systematic LC-MS/MS bioanalytical method development that incorporates plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography. Biomed. Chromatogr. 24, 2-19 (2009).