Validation of bioanalytical chromatographic methods |
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| Affiliation: | 1. Pharmaceutical Institute, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium;2. Department of Chemistry, University of Surrey, Guildford, Surrey GU2 5XH, UK;1. University of Lausanne, Faculty of Law, Criminal Justice and Public Administration, School of Criminal Justice, Lausanne-Dorigny, Switzerland;2. Università Ca’Foscari Venezia, Department of Economics, Venice, Italy;3. Director de la Escuela de Especialización de la Guardia Civil, Valdemoro, Madrid, España;1. Hacettepe University, Department of Chemistry, 06800 Ankara, Turkey;2. Ege University, Faculty of Pharmacy, Analytical Chemistry Department, 35100, Izmir, Turkey;1. Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia;2. Bioavailability Laboratory, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia;3. Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia;1. Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna, Muthgasse 18, A-1190 Vienna, Austria;2. Angothera GmbH, Donau-Oder Kanal IV SW 80, A-2301 Gross-Enzersdorf, Austria |
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| Abstract: | A strategy is discussed for the validation of chromatographic methods that are developed to quantify drugs in biological matrices. Both the validation terminology and the hypothesis testing are briefly reviewed. The emphasis is on the design of the experiments required to allow a reliable conclusion about acceptance or rejection of the bioanalytical method. In particular, it is explained how to evaluate the calibration line, devise experiments to estimate precision and bias and how to determine the stability of the analyte between the time of the sample collection and the analysis of the processed sample. |
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