Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method 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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Thinking about Best Practices for Standards
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2014
ISSN: 1550-7416
DOI: 10.1208/s12248-014-9566-y