References
- Tan A, Hussain S, Musuku A, Massé R. Internal standard response variations during incurred sample analysis by LC-MS/MS: Case by case trouble-shooting. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:3201–3209.
- Chow F, Ocampo A, Vogel P, Lum S, Tran N. Current challenges for FDA-regulated bioanalytical laboratories performing human BA/BE studies; Part III: selected discussion topics in bioanalytical LC/MS/MS method validation. Qual Assur J 2009;12:22–30.
- Van Eeckhaut A, Lanckmans K, Sarre S, Smolders I, Michotte Y. Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:2198–2207.
- Rocci ML Jr, Devanarayan V, Haughey DB, Jardieu P. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J 2007;9: Article 40. Available online at: http://www.aapsj.org,accessed July 2011.
- Timmerman P, Luedtke S, van Amsterdam P, Brudny-Kloeppel M, Lausecker B, Fischmann S, Globig S, et al. Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum. Bioanalysis 2009;1:1049–1056.
- Heinig K, Bucheli F. Fast liquid chromatographic-tandem mass spectrometric (LC-MS-MS) determination of metformin in plasma samples. J Pharm Biomed Anal 2004;34:1005–1011.
- Marques MAS, de Souza Soares A, Pinto OW, Barroso PTW, Pinto DP, Ferreira-Filho M, Werneck-Barroso E. Development and validation for high selective quantitative determination of metformin in human plasma by cation exchanging with normal-phase LC/MS/MS. J Chromatogr B 2007;852:308–316.
- Liu A, Coleman SP. Determination of metformin in human plasma using hydrophilic interaction liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:3695–3700.
- Koseki N, Kawashita H, Niina M, Nagae Y, Masuda N. Development and validation for high selective quantitative determination of metformin in human plasma by cation exchanging with normal-phase LC/MS/MS. J Pharm Biomed Anal 2005;36:1063–1072.
- Ruzilawati AB, Wahab MS, Imran A, Ismail Z, Gan SH. Method development and validation of repaglinide in human plasma by HPLC and its application in pharmacokinetic studies. J Pharm Biomed Anal 2007;43:1831–1835.
- www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf, accessed May 2011.
- www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500018062, accessed May 2011.
- de Boer T, Wieling J. Incurred sample accuracy assessment: design of experiments based on standard addition. Bioanalysis 2011;3:983–992.
- Rocci ML Jr, Devanarayan V, Haughey DB, Jardieu P. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J 2007;9:E336–E343.