Nidhiya J S
☆    

United Arab Emirates,
2019-11-05 05:14
(edited by Nidhiya J S on 2019-11-06 05:08)

Posting: # 20749
Views: 1,834
 

 Bio 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
jag009
★★★

NJ,
2019-11-07 18:52

@ Nidhiya J S
Posting: # 20762
Views: 1,224
 

 Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet

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
Nidhiya J S
☆    

United Arab Emirates,
2019-11-11 09:51

@ jag009
Posting: # 20784
Views: 1,143
 

 Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet

Thank you very much for your valuable input

With best regard
Nidhiya
wienui
★    

Germany, Oman,
2019-11-08 06:14
(edited by wienui on 2019-11-09 01:50)

@ Nidhiya J S
Posting: # 20763
Views: 1,208
 

 Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet

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,

Osama

Osama
Nidhiya J S
☆    

United Arab Emirates,
2019-11-11 09:51

@ wienui
Posting: # 20783
Views: 1,138
 

 Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet

Thank you very much for your valuable input

With best regard
Nidhiya
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