The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation
نویسندگان
چکیده
منابع مشابه
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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A bioanalytical method is a set of procedures involved in the collection, processing, storage, and analysis of a biological matrix for a chemical compound. The availability of selective and sensitive bioanalytical methods is a prerequisite for the generation of reliable data on pharmacokinetics, bioavailability, and bioequivalence of drugs. These methods should allow the quantification of drugs...
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The 2001 US FDA Bioanalytical Method Validation (BMV) guidance document has been widely accepted and adopted by the bioanalytical community worldwide. As such, it has become the cornerstone of regulated bioanalytical laboratory procedure. In recent years, clarifications to these FDA guidelines and subsequent enhancements were discussed at North American-and European-hosted meetings and conferen...
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[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...
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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: The AAPS Journal
سال: 2007
ISSN: 1550-7416
DOI: 10.1208/aapsj0901005