Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
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...
متن کاملRequest for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.
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...
متن کاملFDA 2011 Process Validation Guidance: Process Validation Revisited
Background In January 2011, FDA announced the availability of a final guidance for industry entitled Process Validation: General Principles and Practices (the 2011 Guidance). The 2011 Guidance revises and replaces FDA’s Guidance for industry entitled Guideline on General Principles of Process Validation, issued in May 1987 (the 1987 Guideline). The 2011 Guidance defines process validation as “t...
متن کاملInformal guidance and the FDA.
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of policymaking, as opposed to more formalized procedures like notice-and-comment rulemaking or case-specific adjudication. Using major developments in administrative law and modifi...
متن کاملReview: Bioanalytical method validation – How, how much and why ?
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...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2014
ISSN: 1550-7416
DOI: 10.1208/s12248-014-9696-2