International harmonization of bioanalytical guidance
نویسندگان
چکیده
منابع مشابه
Request 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...
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ژورنال
عنوان ژورنال: Bioanalysis
سال: 2010
ISSN: 1757-6180,1757-6199
DOI: 10.4155/bio.10.39