Dose proportionality [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-07-08 15:21 (5834 d 18:08 ago) – Posting: # 5603
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Dear Stefano!

❝ In a confirmatory assessment of dose proportionality, only the AUC is of interest or proportionality should be demonstrated also for Cmax?


Most people would assess both metrics – with AUC as the primary. All the problems associated with the single point metric Cmax in classical BE (bad surrogate of the rate of absorption, influenced by the extent, high variability, etc.) applies here also...

Would be interesting to get an opinion from our ‘DP-expert’ Martin…

Search the forum for some references.
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