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Tina ★ India, 2014-05-13 18:30 (4422 d 23:29 ago) Posting: # 12938 Views: 5,725 |
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Dear forum members, If the clinical phase of bioequivalence study is conducted before the date of expiry while the bioanalytical phase is carried for 3 months post-expiry of the product, will there be any interference with the bioanalytical values? Kind regards, Tina Edit: Subject line changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2014-05-13 18:58 (4422 d 23:00 ago) @ Tina Posting: # 12939 Views: 4,833 |
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Hi Tina, no problem – if validation of long-term stability covers the time period from first administration to the end of analyses. Hint: The IMPs were administered within their shelf-lives. Out of curiosity: Why do you wait 3+ months to get the samples analyzed? — 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, 2014-05-13 19:08 (4422 d 22:50 ago) @ Helmut Posting: # 12940 Views: 4,784 |
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Hi Hötzi, ❝ Out of curiosity: Why do you wait 3+ months to get the samples analyzed? Otherwise all the waiting during validation would have been completely in vain...  — Pass or fail! ElMaestro |
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Tina ★ India, 2014-05-13 20:04 (4422 d 21:54 ago) @ Helmut Posting: # 12941 Views: 4,832 |
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Thanks Helmut. Bioanalysis took a long time as sample size was 102. Additionally the CRO's HPLC machines werent available to run analysis immediately after the clinical phase. Kind regards, Tina |
Ing. Helmut Schütz