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RegisterBE demonstrated in pilot study [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2006-08-16 14:44 (7243 d 00:51 ago) – Posting: # 218
Views: 10,376
Dear Ahmed,
first have a look at Hermann's post.
It should be possible to claim BE with a pilot study, if
first have a look at Hermann's post.
It should be possible to claim BE with a pilot study, if
- your sample size is at least the minimum required in the legislation you are bound to (e.g., 12 for WHO, EU, USA, CAN, NZ, AUS, Malaysia, Argentina, ASEAN States, RSA [20 for MR products]; 24 for Brazil), and
- you have stated such a 'stop criterion' in your study protocol.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- pilot/pivotal ssk 2006-08-14 09:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pilot/pivotal Helmut 2006-08-14 09:45
- pilot/pivotal Ahmed meeran 2006-08-16 12:02
- BE demonstrated in pilot studyHelmut 2006-08-16 12:44
- pilot/pivotal Essar 2006-11-17 05:48
- pilot/pivotal Helmut 2006-11-17 12:19
- pilot/pivotal Ahmed meeran 2006-08-16 12:02
- pilot/pivotal Helmut 2006-08-14 09:45
Ing. Helmut Schütz