Bioanalytical Method Validation & Its Pharmaceutical Application
Author(s):
Mangalge Mangesh, Ajagunde B.R, Shyamlila Bawage, Boje vivek
Keywords:
Bioanalytical Method Validation, Validation Parameters, Application, FDA & EMA guidelines.
Abstract
Bioanalytical methods, supported a spread of physico-chemical & biological techniques like chromatography, immunoassay & mass spectrometry, must be validated before & through use to offer confidence within the results created. it's the method want to establish that a quantitative analytical method is appropriate for biomedical use. Bioanalytical Method Validation includes all of the trials that determine that a exact method used for quantitative measurement of analytes during a given biological matrix, like blood, plasma, serum, or urine is reliable & reproducible for the intended use. The present document focuses on the consistent evaluation of the key bioanalytical validation parameters is debated. These validation parameters are described, alongside an example of validation methodology applied within the case of chromatographic methods used in bioanalysis, taking in account to the present Food & Drug Administration (FDA) guidelines & EMA guidelines.
Article Details
Unique Paper ID: 152352

Publication Volume & Issue: Volume 8, Issue 3

Page(s): 75 - 80
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