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SIVAPRASAD ☆ India, 2005-05-19 15:29 (6914 d 00:06 ago) Posting: # 16 Views: 8,191 |
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Is there any regulatory criteria/guidelines (other than ANIVSA) for limiting the number of repeats (i.e.subject samples) in Bioequivalence studies. I know that in ANIVSA resolution it was given that the percentage number repeat of should not more than 20% total number of samples analysed |
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H_Rotter ★ Germany, 2005-05-21 19:04 (6911 d 20:32 ago) (edited by H_Rotter on 2006-01-26 15:18) @ SIVAPRASAD Posting: # 17 Views: 6,402 |
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Hi! To my knowledge there is no explicit acceptable %-number for re-analysed samples in BE studies stated in any country's guideline. best regards Hermann P.S.: But you are right with 20% for ANVISA: Resolution - RE nº 896 of 29 May 2003 states 2. Analytical stage e) the analytical protocol shall contain the criteria for the re-analysis of the samples; no more than 20% of the samples may be re-analyzed; ...and also don't forget this one: i) the analytical protocol shall contain the sample's data reintegration criteria; There was an update (RE nº 397 of 12 Nov 2004), but has not been translated into English yet and is not available - even in Portuguese - at ANVISA's website. |
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Helmut ★★★   Vienna, Austria, 2007-09-02 14:29 (6078 d 01:06 ago) @ H_Rotter Posting: # 1049 Views: 5,818 |
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Dear Hermann! ❝ There was an update (RE nº 397 of 12 Nov 2004), but has not been translated into English yet and is not available - even in Portuguese - at ANVISA's website. RE nº 397 is superseded by RE nº 1170 (19 April 2006, in Portuguese); still 20%. — 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