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

posted by wienui  – Germany/Oman, 2019-11-08 08:14 (1573 d 02:15 ago) – Posting: # 20763
Views: 2,699

(edited by wienui on 2019-11-09 02:50)

Hi all,

❝ 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.

And why not? as long as the following requirments for an additional strength biowaiver are fulfilled: successful BE for the higher strength, same manuefacturing process ( by the way the manufacturer could be different), PK linearity with the higher strength, similarity of formulations ( same qualatitative composition, proportionality (5% Rule for EMA) and as you mentioned the similarity of dissolution characteristics to the Biobatch of the higher strength for which BE has been demonstrated.

❝ 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.

Yes, as long as the both strengthes follow the same PK behavior and the pharmacolgical mechanism.

Best regards,



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