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RegisterNarrow therapeutic Drug [Regulatives / Guidelines]
Dear All,
My concern is regarding narrow therapeutic Drug for US FDA submission, FDA release draft product specific guidance for Tacrolimus, phenytoin, warfarin, Levothyroxin and in all recommendation is fully replicated design but serolimus draft guidance recommended two way study design?
What is the best option?
Is go with draft guidance? Or go with fully replicated design as warfarin?
Regards
My concern is regarding narrow therapeutic Drug for US FDA submission, FDA release draft product specific guidance for Tacrolimus, phenytoin, warfarin, Levothyroxin and in all recommendation is fully replicated design but serolimus draft guidance recommended two way study design?
What is the best option?
Is go with draft guidance? Or go with fully replicated design as warfarin?
Regards
Complete thread:
- Narrow therapeutic DrugMahesh M 2015-01-22 13:55 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Narrow therapeutic Drug Mahesh M 2015-01-27 13:53
- Relax Helmut 2015-01-27 15:46
- Narrow therapeutic Drug Mahesh M 2015-01-27 13:53
Ing. Helmut Schütz