RRML - Bioanalytical method validation

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Dr. Adrian Man

Nr. 10(1)/2008

Bioanalytical method validation

Silvia Imre, Laurian Vlase, Daniela Lucia Muntean

Abstract:

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 documents of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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Imre S, Vlase L, Muntean DL. Bioanalytical method validation. Rev Romana Med Lab. 2008;10(1):13-21