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manusyriac ☆ India, 2010-09-28 20:14 (5751 d 00:47 ago) Posting: # 5945 Views: 4,504 |
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Hi Forum Members, Can we use subject samples which is already analyzed for trials during BA BE analysis to check the method reliability if the respective subject samples gave an abbe-rent results initially. Is this an acceptable practice for a Pivotal study? |
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Helmut ★★★   Vienna, Austria, 2010-09-28 20:23 (5751 d 00:38 ago) @ manusyriac Posting: # 5946 Views: 3,851 |
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Dear Manusyriac, it depends on the country you are aiming at. In the U.S. and in Canada, it's acceptable to reanalyse samples (so-called 'Pharmacokinetic Repeats' - you have to have an SOP for that; you cannot simply reanalyse samples because you don't like the result), whereas the EMA definitely does not like this (to say it politely). Hint: Search the Forum for 'pharmacokinetic repeat', 'reanalysis', etc. — 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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manusyriac ☆ India, 2010-09-29 06:56 (5750 d 14:05 ago) @ Helmut Posting: # 5953 Views: 3,979 |
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Hi this is not a pharmacokinetic repeat. they have just reanalysed (from the same vial) the samples which already injected and having an abberent value. Thanks for your kind reply. Manu |
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Helmut ★★★ Vienna, Austria, 2010-09-29 23:37 (5749 d 21:24 ago) @ manusyriac Posting: # 5961 Views: 3,787 |
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Dear Manu! ❝ they have just reanalysed (from the same vial) the samples which already ❝ injected and having an abberent value. Define aberrant. If they can track the result down to a documented (!!) reason like faulty i.st.. addition, bad chromatography, equipment failure, etc. - why not? An SOP and an audit rail is mandatory. — 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 |
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manusyriac ☆ India, 2010-10-05 18:47 (5744 d 02:14 ago) @ Helmut Posting: # 6002 Views: 3,746 |
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Hi HS The respective sample was a suspected mix up with the quality control sample and picked as a repeat as per the SOP. But before repeating the respective sample they reinjected from the same vial to confirm the unusal result under a test folder which is different from the study folder. My question is since the particular sample is showing an unusual result and already picked for a repeat, reinjecting the same sample from the same vial to confirm the result is an acceptable practice or not. hope this will be clear enough to understand the issue. Thanks Manu |
Ing. Helmut Schütz