FDC: BA/BE study enough? [Regulatives / Guidelines]

posted by qualityassurance – 2024-07-03 07:21 (14 d 21:35 ago) – Posting: # 24056
Views: 662

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

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