EMA: Two-Stage Sequential Designs [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2011-10-21 17:01 (4543 d 00:48 ago) – Posting: # 7529
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Dear Outlaw Torn!

❝ Do you have any updates to share about these submissions?


❝ Has any authority commented on the lack of a penalty in stage one in case of successful conclusion (BE obtained)?


One product (=one study) was approved by the German BfArM June this year (submitted May 2010). Two other studies (different drug) were submitted in the meantime. All studies did not go into stage 2 and no α-adjustment was performed (according to the protocol: Potvin’s Method C, power >80; 90% confidence intervals).

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