qualityassurance
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2024-07-03 07:21
(315 d 22:07 ago)

Posting: # 24056
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 FDC: BA/BE study enough? [Regulatives / Guidelines]

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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
(315 d 19:23 ago)

@ qualityassurance
Posting: # 24057
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 FDC: DDI study generally sufficient

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Hi QA,

see the applicable guideline, esp. Section 4.2.
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