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MSimoes ☆ Portugal, 2019-01-07 13:13 (2294 d 14:53 ago) Posting: # 19741 Views: 6,636 |
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Dear BEBAC team, Now that the MSD is dead and bootstrap f2 finally king  , I would like your opinion on a good (and free) software for trustable calculation of bootstrap f2. I have been using DDSolver, but recently I heard that the Spanish agency replied to a dossier submission saying that it is not acceptable because of miscalculations. We are now moving to Ph-Eq software, as I have seen some posts here in the BEBAC forum. What is your opinion on these softwares, do you know why the DDSolver is not recommended? What about Ph-Eq, any feedback? It is not so user-friendly as the DDSolver, that was my first impression. I am a pharmacist, not expert in statistics or maths It is very difficult sometimes to discriminate the adequacy between tools... I would appreciate your kind support Thanks to you all, And a Happy New Year! — Regards, MSimoes |
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Shuanghe ★★ Spain, 2019-01-07 14:15 (2294 d 13:51 ago) @ MSimoes Posting: # 19742 Views: 5,615 |
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Dear MSimoes, ❝ I have been using DDSolver, but recently I heard that the Spanish agency replied to a dossier submission saying that it is not acceptable because of miscalculations. From the information I got from one meeting with the agency, they use R that was developed by a professor in certain university. I suggested that they should publish the code with the seed number so everyone can use and reproducibility wouldn't be an issue. Haven't seen any thing published yet. ❝ do you know why the DDSolver is not recommended? I've never used DDSolver's calculation for f2 or bootstrapped f2 for regulatory submission. I have no idea how internal code of DDSolver works but from the f2 calculation I saw, it seems that the code doesn't evaluate if your number of points is valid according to EU or US guidance (By that I mean to say the CV% of early points, how many points > 85% release etc). the results of f2 depends on how you select the points. If bootstrapped f2 also works similarly, then I wouldn't be surprised if the agency refuse to accept it. ❝ What about Ph-Eq, any feedback? Well, the result of this program is not reproducible. You'll find Helmut's about this in this forum. however, some articles were published using this program and one of the authors is from Spanish agency, so I guess that you can try it.  — All the best, Shuanghe |
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MSimoes ☆ Portugal, 2019-01-07 17:32 (2294 d 10:34 ago) @ Shuanghe Posting: # 19747 Views: 5,605 |
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Dear Shuanghe, Thanks for your feedback! ❝ From the information I got from one meeting with the agency, they use R that was developed by a professor in certain university. I suggested that they should publish the code with the seed number so everyone can use and reproducibility wouldn't be an issue. Haven't seen any thing published yet. Very good idea! ❝ Well, the result of this program is not reproducible. You'll find Helmut's about this in this forum. however, some articles were published using this program and one of the authors is from Spanish agency, so I guess that you can try it. Yes, I saw it, thanks! ... Well, what are the options to do it right? No programming involved, please I also have JMP software, from SAS.Once again, thanks for your help. — Regards, MSimoes |
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ElMaestro ★★★ Denmark, 2019-01-07 17:39 (2294 d 10:27 ago) @ MSimoes Posting: # 19748 Views: 5,644 |
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Hi, ❝ Yes, I saw it, thanks! ... Well, what are the options to do it right? No programming involved, please if it is just a single dataset or two then send it (/them) here. Use the forum's email option. I will send you the result by email. — Pass or fail! ElMaestro |
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MSimoes ☆ Portugal, 2019-01-07 18:58 (2294 d 09:08 ago) @ MSimoes Posting: # 19753 Views: 5,642 |
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Thanks everyone for your help! I've read about the bootf2BCA in this forum, it seems to create huge files! It seems we still need an optimized tool, despite all the good progress so far. I will also try this one, at least there is no warning of lack of reproducibility (so far). And I will be alert to any news on this. Thanks! — Regards, MSimoes |
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yjlee168 ★★★   Kaohsiung, Taiwan, 2019-01-07 18:07 (2294 d 09:59 ago) @ Shuanghe Posting: # 19750 Views: 5,778 |
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Hi ❝ From the information I got from one meeting with the agency, they use R that was developed by a professor in certain university. bootf2BCA? if yes, it can be downloaded from SourceForge. Detlew is the first one to report this package in this Forum, as far as I can remember. In addition, Poland is the country that the developer comes from. He is also the developer of PhEq_bootstrap. ############################################################# bootf2BCA v1.1 Author: Aleksander Mendyk Chair of Pharmaceutical Technology and Biopharmaceutics Faculty of Pharmacy Jagiellonian University-Medical College Medyczna 9 St 30-688 Kraków, Poland phone: +48-12-6205-604 e-mail: [email protected], [email protected] ############################################################ — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
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Shuanghe ★★ Spain, 2019-01-07 18:22 (2294 d 09:44 ago) @ yjlee168 Posting: # 19752 Views: 5,647 |
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Hi Yung-jin, ❝ bootf2BCA? if yes, it can be downloaded from SourceForge. Detlew is the first one to report this package in this Forum, as far as I can remember. In addition, Poland is the country that the developer comes from. He is also the developer of PhEq_bootstrap. Thanks. I almost forgot this. I saw Detlew's post some time ago. I don't know if this is the one the agency meant. I had the impression that the professor is working in certain university in Spain, but again, I'm not sure since the name was never mentioned in the meeting. In any case, now we have an additional option to try. — All the best, Shuanghe |
Ing. Helmut Schütz