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

posted by Nidhiya J S – United Arab Emirates, 2019-11-05 06:14 (558 d 15:17 ago) – Posting: # 20749
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(edited by Nidhiya J S on 2019-11-06 06:08)

Dear All,

Greetings!

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 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.


Waiting for your valuable comments.

With Regards,

Nidhiya

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