importance of bioanalytical validation [Bioanalytics]

posted by averroes1304 – Morocco, 2019-03-27 11:55 (574 d 22:26 ago) – Posting: # 20091
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(edited by mittyri on 2019-03-27 13:51)

Dear all,

could you explain to me the importance of bioanalytical validation in bioequivalence studies? is it really critical and important to perform the bioanalytical validation exercise? knowing that the purpose of bioequivalence studies is only to highlight differences in bioavailability between the test and reference drug and that this difference will be highlighted in all cases even with an invalidated analytical method and that chance cannot be the only factor in case of bioequivalence between two drugs with an invalidated analytical method..... is it scientifically acceptable to use analytical methods published in the literature?

Best regards,


Edit: Category changed; see also this post #1[Mittyri]

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