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zeynep ☆ Turkey, 2019-10-24 14:22 (1875 d 21:40 ago) Posting: # 20718 Views: 4,589 |
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Hello, What will be the number of standby samples in a Bioequivalence study? or what will be the percentage of standby samples to the total sample size? Thank you, Best Regards, Zeynep |
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Ohlbe ★★★ France, 2019-10-24 15:34 (1875 d 20:28 ago) @ zeynep Posting: # 20719 Views: 4,138 |
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Dear Zeynep, ❝ What will be the number of standby samples in a Bioequivalence study? ❝ or what will be the percentage of standby samples to the total sample size? 1. What do you call "standby samples" ? 2. For which authority / region ? — Regards Ohlbe |
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zeynep ☆ Turkey, 2019-10-24 16:21 (1875 d 19:41 ago) @ Ohlbe Posting: # 20720 Views: 4,167 |
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❝ 1. What do you call "standby samples" ? ❝ 2. For which authority / region ? Dear Ohlbe, Standby samples are the reserve samples. I am asking for TR MOH but we follow primarily EMA and/or FDA guidelines. Best Regards Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2019-10-24 16:32 (1875 d 19:31 ago) @ zeynep Posting: # 20721 Views: 4,103 |
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Merhaba Zeynep, ❝ Standby samples are the reserve samples. Still not clear what you mean by that. Once you dosed a subject, you have to analyze the samples. — 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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ElMaestro ★★★ Denmark, 2019-10-24 16:38 (1875 d 19:24 ago) @ Helmut Posting: # 20722 Views: 4,071 |
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Hi all ❝ ❝ Standby samples are the reserve samples. ❝ ❝ Still not clear what you mean by that. Once you dosed a subject, you have to analyze the samples. I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects? — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2019-10-24 19:59 (1875 d 16:03 ago) @ ElMaestro Posting: # 20723 Views: 4,114 |
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Dear ElMAestro, ❝ I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects? Dunno, as retention samples (in the initial title of the thread) is the FDA terminology for investigational products (test article in FDA-speak) to be kept at the site after the trial. — Regards Ohlbe |
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jag009 ★★★ NJ, 2019-10-24 21:39 (1875 d 14:23 ago) @ ElMaestro Posting: # 20724 Views: 4,082 |
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Hi El, ❝ I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects? Dont tell me he has samples from standby subjects  |
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Ajit Thorat ☆ India, 2019-10-30 12:31 (1869 d 22:31 ago) @ zeynep Posting: # 20733 Views: 3,970 |
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❝ Standby samples are the reserve samples. ❝ I am asking for TR MOH but we follow primarily EMA and/or FDA guidelines. Dear zeynep For USFDA: Retention samples (Investigational medicinal product Test & Reference) The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application.For solid oral dosage forms (e.g., tablets, capsules), an upper limit of 300 units each for the test article and reference standard can be considered sufficient to meet the five times quantity. Thanks Ajit Thorat Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz