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EMA MR Draft Guidelines Application [Regulatives / Guidelines]

posted by Jay – India, 2013-12-23 15:54 (4565 d 15:58 ago) – Posting: # 12098
Views: 3,349

Thanks Helmut for the reply.

Hope the Guideline gets published soon and provides clarity for truncation point of pAUC. If we conduct BE as per draft MR GL, can we submit it even if new MR GL is still in draft?

Complete thread:

EMA MR Draft Guidelines Application Jay 2013-09-16 15:39
- EMA MR Draft Guidelines Application jag009 2013-09-16 17:30
- EMA MR Draft Guidelines Application Helmut 2013-09-17 13:35
  - EMA MR Draft Guidelines Application Jay 2013-12-23 11:00
    - EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
      - EMA MR Draft Guidelines ApplicationJay 2013-12-23 14:54
        
        Science first! Helmut 2013-12-23 15:41

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