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Helmut ★★★   Vienna, Austria, 2016-07-07 15:16 (2843 d 09:33 ago) Posting: # 16473 Views: 7,869 |
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Dear all, does anybody know how to estimate the sample size for the FDA’s in vitro PBE of budesonide? I’m completely lost… — 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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BE-proff ● 2016-07-07 15:36 (2843 d 09:13 ago) @ Helmut Posting: # 16474 Views: 7,049 |
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Hi Helmut, I think the option is to request FDA how to do it. They are responsive guys so they will hardly refuse you )) |
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Helmut ★★★ Vienna, Austria, 2016-07-07 15:44 (2843 d 09:05 ago) @ BE-proff Posting: # 16475 Views: 7,036 |
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Hi BE-proff ❝ I think the option is to request FDA how to do it. ❝ They are responsive guys so they will hardly refuse you )) I would not bet on that. F.i. the FDA’s SAS-code for ABE in the partial replicate design (if no scaling is applied) fails to converge due to the over-specified model (regardless which software one uses). John sent a letter to Donald Schuirmann asking for a clarification and never received an answer.  — 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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ElMaestro ★★★ Denmark, 2016-07-07 15:57 (2843 d 08:52 ago) @ Helmut Posting: # 16476 Views: 6,961 |
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Hi Hötzi, I believe you need to set up a resampling/bootstrap method. This is where communication is of utmost importance. In companies where sample size for BE is of interest, it usually takes 5 minutes and a minimum of googling to get a sample size. Here it will take about 100 hrs of programming time and you cannot validate it because noone has a dataset with known result. Tough sh!t. — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2016-07-07 16:12 (2843 d 08:37 ago) @ ElMaestro Posting: # 16477 Views: 7,060 |
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Hi ElMaestro, ❝ I believe you need to set up a resampling/bootstrap method. Yes, that was my first idea as well. I have some preliminary data to play with. ❝ […] Here it will take about 100 hrs of programming time and you cannot validate it because noone has a dataset with known result. Tough sh!t. Yep. At least the guidance contains a dataset. — 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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mittyri ★★ Russia, 2016-07-07 16:17 (2843 d 08:32 ago) @ Helmut Posting: # 16478 Views: 7,002 |
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Hi Helmut, If I understood correctly, simulation is the best choice, something like this: Morgan B, Strickland H. Performance Properties of the Population Bioequivalence Approach for In Vitro Delivered Dose for Orally Inhaled Respiratory Products. The AAPS Journal. 2014;16(1):89-100. doi:10.1208/s12248-013-9543-x. Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"?  — Kind regards, Mittyri |
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Helmut ★★★ Vienna, Austria, 2016-07-07 16:25 (2843 d 08:24 ago) @ mittyri Posting: # 16479 Views: 7,087 |
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Hi mittyri, ❝ If I understood correctly, simulation is the best choice, something like this […] THX; looks promising! ❝ Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"? I wouldn’t say so. IMHO there are other things on the to-do-list with a higher rate of importance. AFAIK this method is required by the FDA only for two products: Budesonide Suspension/Inhalation and Intravenous Iron Sucrose. — 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 |
Ing. Helmut Schütz