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RegisterBio waiver for lower strength (250mg) Mycophenolate mofetil tablet [Regulatives / Guidelines]
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
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
Complete thread:
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-05 06:14 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet jag009 2019-11-07 19:52
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-11 10:51
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet wienui 2019-11-08 07:14
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-11 10:51
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet jag009 2019-11-07 19:52
Ing. Helmut Schütz