Population Bioequivalence on In-Vitro data [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2015-02-07 11:16 (4150 d 00:51 ago) – Posting: # 14386
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Hi Anil,

❝ Can any one please help me on how to perform Population Bioequivalence on In-Vitro data for US-FDA submission. Is there any specific guideline available for these type of studies.


Perhaps you're looking for the Budesonide draft guidance?
—
Pass or fail!
ElMaestro

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