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kaushik089 ★ India, 2012-08-15 20:17 (5066 d 09:12 ago) Posting: # 9065 Views: 2,264 |
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hello all, Can anybody share any FDA document, which shows (/documents) that the minimum sample size (approx.24+standby) for a pivotal study? Its a ba/be in healthy volunteers US Submission. Kindly attach the supportive documents if u have. Thanx in advance, kaushik |
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Helmut ★★★   Vienna, Austria, 2012-08-15 20:32 (5066 d 08:57 ago) @ kaushik089 Posting: # 9067 Views: 1,869 |
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Hi Kaushik! Don’t you know this post and the Forum’s Policy? The minimum sample size for the FDA is 12, provided the study was planned for a power of 80–90%. If you have a formulation with a small CVintra and expect a GMR not too far away from 100%, no need to go with 24+. — 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 |
Ing. Helmut Schütz