Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-06 22:21 (1155 d 15:10 ago) – Posting: # 20950
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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?

Thx
john

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