ElMaestro ★★★ Denmark, 2017-09-08 19:24 (2393 d 11:55 ago) Posting: # 17795 Views: 8,947 |
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Hi all, here's the pretty solution to a terrible challenge, originating from this guidance and which is now applied to about 40 different products. It basically involves the application of an idea that is 40 years old and which was totally impractical at the time it was invented, and using it on FDA's pop BE approach. No-one has been able to deal with it analytically because the math gets too complicated (in fact, FDA's way to calculate the confidence limit for Eta is in itself an approximation). A good weekend to all of you. — Pass or fail! ElMaestro |
Helmut ★★★ Vienna, Austria, 2017-09-08 20:05 (2393 d 11:13 ago) @ ElMaestro Posting: # 17796 Views: 8,013 |
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Hi ElMaestro, nice. Can’t say that I understand much (if anything at all). The fruit of your love-affair looks impressive. What I like: Received on August 2, 2017 No peer-review of letters to the editor? Detlew and I were not so lucky in the past… — 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 |
ElMaestro ★★★ Denmark, 2017-09-08 20:42 (2393 d 10:36 ago) @ Helmut Posting: # 17797 Views: 7,942 |
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Hi Hötzi, ❝ What I like: ❝ Received on August 2, 2017 ❝ in final form, August 2, 2017 ❝ No peer-review of letters to the editor? Detlew and I were not so lucky in the past… This paper was subjected to all kinds of events as far as I understand from my discussion with the author :
Even though the author does perhaps not agree 100% with the negative reviewer, the author is firmly of the opinion that editor handled this in a quite OK fashion. I heard in my local supermarket that the author is currently looking for flighs to Prague on Sept 20. If you know the BioBridges people, ask them if there are any speaker dropouts then he could perhaps jump in and volunteer a talk about GCP/GLP findings in BE trials, Bootstrapping and how it relates to BE, or something else. — Pass or fail! ElMaestro |
Helmut ★★★ Vienna, Austria, 2017-09-09 14:29 (2392 d 16:49 ago) @ ElMaestro Posting: # 17798 Views: 7,884 |
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Hi ElMaestro, amazing story. THX for sounding the unfathomable depths of the publication process. PS: You have Mehl in your Mehlschachtel. — 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 |
mahmoud-teaima ★ 2017-09-10 18:12 (2391 d 13:07 ago) @ ElMaestro Posting: # 17799 Views: 7,889 |
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Thanks for ElMaestro, for this valuable post. Please find attached the published letter as an image (sorry for the poor quality). I have the file as pdf, so if anyone is interested to get it, just let me know and i will send it via private email. Greetings. Edit: Images removed. [Helmut] — Mahmoud Teaima, PhD. |
ElMaestro ★★★ Denmark, 2017-09-10 18:23 (2391 d 12:55 ago) @ mahmoud-teaima Posting: # 17800 Views: 7,807 |
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Dear Mahmoud Teaima, ❝ Please find attached the published letter as an image (sorry for the poor quality). The publication is copyrighted and currently behind a paywall; no-one except the publisher can OK its publication elsewhere like here. The Bebac forum administrator can get in quite some legal trouble if the paper is published on his forum without permission. I recommend to be careful and state explicitly if permission has been granted from the publisher. — Pass or fail! ElMaestro |
mahmoud-teaima ★ 2017-09-11 15:26 (2390 d 15:53 ago) @ ElMaestro Posting: # 17801 Views: 7,789 |
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Dear ElMaestro, Thanks for the advice. Sorry for publishing it on the forum. I can use it personally. Greetings. — Mahmoud Teaima, PhD. |