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Bioanalytical method development and validation
Bioanalytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like saliva, urine, plasma, serum. Development and validation of bioanalytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Bioanalytical method development consists of three essential interrelated parts sample preparation, chromatographic separation and detection by using proper analytical method. Validation of a Bioanalytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bioanalytical application. The validation is further divided into 3 segments full validation, partial validation, and cross validation each of which has its own purpose. This review describes mainly the various aspects for development of bioanalytical method and for the validation of bioanalytical methods. Also the Bioanalytical method transfer is also described.
Bioanalytical method development and validation
Bioanalytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like saliva, urine, plasma, serum. Development and validation of bioanalytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Bioanalytical method development consists of three essential interrelated parts sample preparation, chromatographic separation and detection by using proper analytical method. Validation of a Bioanalytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bioanalytical application. The validation is further divided into 3 segments full validation, partial validation, and cross validation each of which has its own purpose. This review describes mainly the various aspects for development of bioanalytical method and for the validation of bioanalytical methods. Also the Bioanalytical method transfer is also described.
Bioanalytical method development and validation
Welankiwar, A. S. (author) / Charde, Manoj S. (author) / Kumar, Jitendra (author) / Chakole, R. D. (author)
2014-01-01
International Journal of Advances in Pharmaceutical Analysis; Vol 3 No 4 (2013): Oct-Dec; 90-94 ; 2277-9353 ; 10.7439/ijapa.v3i4
Article (Journal)
Electronic Resource
English
DDC:
690
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