Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-06 20:21  – Posting: # 20950
Views: 671

Hi Helmut (and guys and girls)

» Had that on this side of the pond as well (called a “hybrid application”); multiphasic product. Cmax was doable but only with expanded limits.

Do you know of any articles which say that Cmax is not a primary parameter (for equivalence) for ER product, when compared to IR?


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