Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-07 19:52 (443 d 19:36 ago) – Posting: # 20762
Views: 2,063

Hi,

» Please, I would like to know that, with the In vitro comparative dissolution study report can we waive off BE In vivo study with in vitro comparative dissolution study for the lower strength for Mycophenolate mofetil tablet 250mg or do we require separate BE study for the lower strength.

Are the strengths formulation proportional? FDA or EMA?

» And also I would like to know that whether similar approach can be taken for all the pro-drug where the metabolite of the drug is pharmacologically active.

FDA yes. Take a look at enalapril BE guidance.

J

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