qualityassurance
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2024-07-03 07:21
(225 d 05:04 ago)

Posting: # 24056
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 FDC: 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
Helmut
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2024-07-03 10:05
(225 d 02:20 ago)

@ qualityassurance
Posting: # 24057
Views: 1,470
 

 FDC: DDI study generally sufficient

Hi QA,

see the applicable guideline, esp. Section 4.2.

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