Profile comparison requirements [Regulatives / Guidelines]
Dear friends,
Is it must to have matching dissolution profile of all 3 registration batches with RLD for ANDA filing purpose?
If 2 batches have F2 50+ but one below 50, then what?
Please help.
Thanks
Is it must to have matching dissolution profile of all 3 registration batches with RLD for ANDA filing purpose?
If 2 batches have F2 50+ but one below 50, then what?
Please help.
Thanks
Complete thread:
- Profile comparison requirementsPriyalAayushi 2018-03-13 04:09 [Regulatives / Guidelines]
- Homework Helmut 2018-03-13 13:36
- Profile comparison requirements jag009 2018-03-15 21:45