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Rosy ☆ Mexico, 2019-01-21 18:37 (2280 d 11:51 ago) Posting: # 19797 Views: 9,433 |
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Hello! Anyone who uses PASS software for the Sample size calculation??? Edit: Category changed; see also this post #1. [Helmut] |
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ashwinim13 ☆ India, 2019-01-24 13:30 (2277 d 16:58 ago) @ Rosy Posting: # 19802 Views: 8,475 |
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❝ Hello! Anyone who uses PASS software for the Sample size calculation??? I am using PASS from last seven years for BA BE and Phase III trial sample size estimations.Its very good and user friendly software |
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Rosy ☆ Mexico, 2019-01-29 00:47 (2273 d 05:41 ago) @ ashwinim13 Posting: # 19819 Views: 8,313 |
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❝ I am using PASS from last seven years for BA BE and Phase III trial sample size estimations.Its very good and user friendly software. I know it's easy, i just started to use. is any way to calculate CV intrasubject from IC's of a BE study (like power tost)???? |
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mittyri ★★ Russia, 2019-01-31 23:45 (2270 d 06:43 ago) @ Rosy Posting: # 19833 Views: 8,231 |
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Hi Rosy, ❝ I know it's easy, i just started to use. is any way to calculate CV intrasubject from IC's of a BE study (like power tost)???? If R is not allowed, may be you can try with FARTSSIE? User-friendly and Excel-based — Kind regards, Mittyri |
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Rosy ☆ Mexico, 2019-02-08 19:01 (2262 d 11:27 ago) @ mittyri Posting: # 19888 Views: 7,967 |
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Dear Mittyri, ❝ If R is not allowed, may be you can try with FARTSSIE? ❝ User-friendly and Excel-based Sorry i did't see this post reply, thank u so much. Kind Regards |
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BE-proff ● 2019-01-24 14:33 (2277 d 15:55 ago) @ Rosy Posting: # 19803 Views: 8,514 |
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Hi Rosy, It is better to use PowerTOST for bioequivalence. PASS is good for clinical endpoints studies. |
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Rosy ☆ Mexico, 2019-01-29 00:52 (2273 d 05:36 ago) @ BE-proff Posting: # 19820 Views: 8,321 |
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❝ It is better to use PowerTOST for bioequivalence. ❝ PASS is good for clinical endpoints studies. I know, i really like PowerTOST and also is free but my regulation ask for the use of "Confidence Software" then i chose to use PASS because the friendly interfase |
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Helmut ★★★   Vienna, Austria, 2019-01-29 04:54 (2273 d 01:34 ago) @ Rosy Posting: # 19821 Views: 8,278 |
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Hi Rosy, ❝ […] my regulation ask for the use of "Confidence Software" … We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please? — 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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Rosy ☆ Mexico, 2019-01-31 20:10 (2270 d 10:18 ago) @ Helmut Posting: # 19831 Views: 8,217 |
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❝ We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please? Dear Helmut, There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed  |
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ElMaestro ★★★ Denmark, 2019-01-31 22:43 (2270 d 07:45 ago) @ Rosy Posting: # 19832 Views: 8,179 |
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Hi Rosy, ❝ There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed I have no idea where such a recommendation would come from? Maybe you can try EFG?? As I recall it, it was written by a former regulator and it only handles the standard design with any level of credibility (and I am not saying any high level of credibility). — Pass or fail! ElMaestro |
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Rosy ☆ Mexico, 2019-02-01 21:51 (2269 d 08:36 ago) (edited on 2019-02-02 01:29) @ ElMaestro Posting: # 19837 Views: 8,200 |
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Dear ElMaestro, ❝ I have no idea where such a recommendation would come from? I work at CRO, and this recommendation came from the health authority in Mexico (specifically during an audit), so we had to acomplish it. ❝ As I recall it, it was written by a former regulator and it only handles the standard design with any level of credibility (and I am not saying any high level of credibility). Thank u so much, i will try it. Kind Regards :) |
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d_labes ★★★ Berlin, Germany, 2019-02-02 14:50 (2268 d 15:38 ago) @ Rosy Posting: # 19842 Views: 8,112 |
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Dear Rosy, ❝ ❝ We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please? ❝ ❝ There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed IMHO such an statement is absolutely nonsense or at least outright bizarre. Much more bizarre is the fact that there is no written statement about such a recommendation. Regarding the regulatory acceptance of PowerTOST in other jurisdictions you may find this thread. Look into this post to find what an opinion the FDA has regarding the use of the R language at all. Maybe this gives you some arguments which help in an other audit to convince the auditor(s) in respect of using R packages. Any other Mexican member out there with same observation? — Regards, Detlew |
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Rosy ☆ Mexico, 2019-02-06 18:43 (2264 d 11:45 ago) @ d_labes Posting: # 19884 Views: 8,124 |
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Dear d_labes: ❝ Maybe this gives you some arguments which help in an other audit to convince the auditor(s) in respect of using R packages. thank u, i hope Mexican authorities can understand that. |
Ing. Helmut Schütz