Bioanalytical Method Validation and Its Pharmaceutical Application- A Review
نویسندگان
چکیده
منابع مشابه
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Bioanalytical method validation
A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...
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The reliability of analytical findings is a matter of great importance in forensic and clinical toxicology, as it is of course a prerequisite for correct interpretation of toxicological findings. Unreliable results might not only be contested in court, but could also lead to unjustified legal consequences for the defendant or to wrong treatment of the patient. The importance of validation, at l...
متن کاملof Pharmaceutical Analysis Review on Analytical Method Development and Validation
Analytical methods development must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications.Analytical method followed by process of establishing evidence that provides a high deg...
متن کاملBioanalytical Method Validation: A Quality Assurance Auditor View Point
ISSN:0975-1459 Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for a quantitative measurement of analytes in a given biological matrix is selective, sensitive, reliable and reproducible for the intended use. Any method developed for the analysis of analytes in biological fluids must yield consistent results despite the variations in ...
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ژورنال
عنوان ژورنال: Pharmaceutica Analytica Acta
سال: 2014
ISSN: 2153-2435
DOI: 10.4172/2153-2435.1000288