Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation

Bioanalysis

Volumn 1, Issue 5, 2009, Pages 877-881

  Smith, Graeme ^a  

^a Department of Bioanalysis Huntingdon Life Sciences ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; CHEMICAL ANALYSIS; EUROPE; STANDARD; VALIDATION STUDY;

CHEMISTRY TECHNIQUES, ANALYTICAL; EUROPE; PHARMACEUTICAL PREPARATIONS; VALIDATION STUDIES AS TOPIC;

EID: 79953309977     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.94     Document Type: Review

References (4)

1. Shah V P, Midha KK, Dighe SV et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9, 588-592 (1992).
2. Shah V P, Midha KK, Findlay JW et al. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17, 1551-1557 (2000).
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(4), 1962-1973 (2007).
4. Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 9(5), E43-E46. (2007).