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Back to the forum  Query: 2018-02-24 00:59 CET (UTC+1h)
 

AUC infinity [Study As­sess­ment]

posted by mokhtar saleh - Egypt, 2017-10-24 16:58  - Posting: # 17912
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Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ??? I mean in a Bioequivalence study the C.I of cmax and AUC0-t were in the accepted range of Bioequivalence but AUC0-inf outside the range, can the study be accepted??
Although the drug is not a highly variable drug????


Edit: Please follow the Forum’s Policy. [Helmut]

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