Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?
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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ژورنال
عنوان ژورنال: Journal of Pharmaceutical and Biomedical Analysis
سال: 2019
ISSN: 0731-7085
DOI: 10.1016/j.jpba.2018.12.030