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RegisterFDC: BA/BE study enough? [Regulatives / Guidelines]
Dear Forum members,
In case if mono forms of products are approved in EMA, will FDC of these mono forms be approved in EMA based on BA/BE study (with PK end points) only? or it is required to perform any other study?
Regards,
QA
In case if mono forms of products are approved in EMA, will FDC of these mono forms be approved in EMA based on BA/BE study (with PK end points) only? or it is required to perform any other study?
Regards,
QA
Complete thread:
- FDC: BA/BE study enough?qualityassurance 2024-07-03 05:21 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDC: DDI study generally sufficient Helmut 2024-07-03 08:05
Ing. Helmut Schütz