qualityassurance ★ 2024-07-03 07:21 (225 d 05:04 ago) Posting: # 24056 Views: 1,918 |
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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 ★★★ ![]() ![]() Vienna, Austria, 2024-07-03 10:05 (225 d 02:20 ago) @ qualityassurance Posting: # 24057 Views: 1,470 |
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