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debabrata ● 2005-10-19 08:58 (6761 d 14:27 ago) Posting: # 42 Views: 21,646 |
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According to Canadian Regulatory requirement, what is the retention sample quantity that has to be kept in the CRO after completion of the study? Also what is the retention period? |
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Helmut ★★★   Vienna, Austria, 2005-10-19 13:22 (6761 d 10:03 ago) @ debabrata Posting: # 43 Views: 20,244 |
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Hi! 'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states: Retention of Samples It is recommended that samples of the test and reference drug products used in the comparative bioavailability study(ies), and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn. — 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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debabrata ● 2005-10-20 09:22 (6760 d 14:03 ago) @ debabrata Posting: # 44 Views: 16,643 |
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❝ According to Canadian Regulatory requirement, what is the retention sample quantity that has to be kept in the CRO after completion of the study? Also what is the retention period? Is there any specific retention quantity that has to be kept in the CRO like US FDA? |
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H_Rotter ★ Germany, 2005-10-20 17:43 (6760 d 05:42 ago) @ debabrata Posting: # 45 Views: 16,439 |
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Ing. Helmut Schütz