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MSimoes ☆ Portugal, 2019-07-17 20:13 (1972 d 18:11 ago) Posting: # 20383 Views: 4,277 |
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Dear BEBAC team, What is your position on comparing dissolution profiles with different number of units? As far as I know, guidelines state one should use 12 units of each batch. However, sometimes and for QC reasons, we have 18 units of one batch and 12 units of another. I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience? Thanks in advance, Marta — Regards, MSimoes |
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ElMaestro ★★★ Denmark, 2019-07-17 23:02 (1972 d 15:22 ago) @ MSimoes Posting: # 20384 Views: 3,469 |
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Hi MSimoes, ❝ I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience? That should generally be ok, in my experience. — Pass or fail! ElMaestro |
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MSimoes ☆ Portugal, 2019-07-18 12:22 (1972 d 02:02 ago) @ ElMaestro Posting: # 20385 Views: 3,441 |
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Dear ElMaestro, Many thanks for your feedback! Marta — Regards, MSimoes |
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Helmut ★★★   Vienna, Austria, 2019-07-18 15:06 (1971 d 23:18 ago) @ MSimoes Posting: # 20386 Views: 3,516 |
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Hi Marta, ❝ […] Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? ƒ2 and bootstrap are fine. Mahalanobis is dead. — 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