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mathews ● 2007-09-21 14:51 (6858 d 04:13 ago) Posting: # 1108 Views: 4,368 |
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Dear All, Please tell me the when we terminate a bioequivalence study for statistical reasons? what are the crieterion involved in the termination? can u refer to any guidelines? thanks mathews |
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Helmut ★★★   Vienna, Austria, 2007-09-21 15:35 (6858 d 03:29 ago) @ mathews Posting: # 1111 Views: 3,638 |
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Dear Mathews! ❝ ... terminate a bioequivalence study for statistical reasons?  Can you please give some more information? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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mathews ● 2007-09-21 15:52 (6858 d 03:12 ago) @ Helmut Posting: # 1112 Views: 3,547 |
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Dear HS According to ICH E6 guidelines on GCP consolidated guidelines sections 4.12, 5.21 and 6.9.4 defines the pre mature termination /suspenction of a trial, especially section 6.9.4 deals about termination of trials for statistical reasons but does not give the termination crieteria. could u please clarify on this. thanks mathews |
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Ohlbe ★★★ France, 2007-09-24 11:17 (6855 d 07:46 ago) @ mathews Posting: # 1117 Views: 3,508 |
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Dear mathews, IMHO these provisions would rather apply for Phase III trials where you may decide to interrupt your trial based on the results of an interim analysis (e.g. if you have reached a statistically significant difference between your treatment groups or shown a pre-defined level of effect). I can't think of any situation where you would decide to interrupt your BE trial based on statistical considerations. Regards Ohlbe |
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mathews ● 2007-09-25 10:25 (6854 d 08:38 ago) @ Ohlbe Posting: # 1130 Views: 3,543 |
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Dear Ohlbe, Thanks for ur reply  Regards Mathews |
Ing. Helmut Schütz