Author:
Wille Sarah M. R.,Peters Frank T.,Di Fazio Vincent,Samyn Nele
Publisher
Springer Science and Business Media LLC
Subject
Safety, Risk, Reliability and Quality,Instrumentation,General Chemical Engineering,General Chemistry
Reference39 articles.
1. Guidance for industry-Bioanalytical method validation (2001) US Department of health and human services, food and drug administration, center for drug evaluation and research, center for veterinary medicine. http://www.fda.gov/cder/guidance/index.htm . Accessed 10 Sept 2010
2. Guideline on validation of bioanalytical methods (2009) Committee for medicinal products for human use (CHMP), European medicines agency (EMEA). Document 192217/2009 http://www.emea.eu.int . Accessed 10 Sept 2010
3. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S (1992) Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci 81:309–312
4. Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Bioanalytical method validation: a revisit with a decade of progress. Pharm Res 17:1155–1551
5. Savoie N, Booth BP, Bradley T, Garofolo F, Hughes NC, Hussain S, King SP, Lindsay M, Lowes S, Ormsby E, Phull R, Rocci ML, Vallano PT, Viau A, Zhu Z (2009) The 2nd calibration and validation group workshop on recent issues in good laboratory practice bioanalysis. Bioanalysis 1:19–30
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