mittyri ★★ Russia, 2018-06-09 20:39 (1002 d 00:04 ago) Posting: # 18878 Views: 4,349 |
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Dear All! I was looking into the abstracts published after annual PAGE meeting (and had a pleasure to discuss it with some authors). I collected some of them here for your review:
AFAIK regulatories are also interested and funding some of them. What do you think? Is time of deconvolution over? Could we see new class A IVIVC using that approach soon? — Kind regards, Mittyri |
jag009 ★★★ NJ, 2018-06-13 00:40 (998 d 20:03 ago) @ mittyri Posting: # 18894 Views: 3,640 |
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Hi, » What do you think? Is time of deconvolution over? Could we see new class A IVIVC using that approach soon? Afraid so (more or less). I spoke w my former boss who is now working in FDA and he told me about it... John |
elba.romero ☆ Guadalajara, Mexico, 2018-10-18 23:17 (870 d 21:25 ago) @ mittyri Posting: # 19474 Views: 3,161 |
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» The investigators are actively trying to raise the level of the models from in vivo level to in vitro in vivo level. » AFAIK regulatories are also interested and funding some of them. » What do you think? Is time of deconvolution over? Could we see new class A IVIVC using that approach soon? Yes!!!! Indeed ![]() Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] — Regards, -- Elba Romero Área de Farmacometría Universidad de Guadalajara, México lindo y querido... |
mittyri ★★ Russia, 2019-06-21 11:50 (625 d 08:52 ago) @ mittyri Posting: # 20356 Views: 2,349 |
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Dear All! here's the update from the latest PAGE meeting:
— Kind regards, Mittyri |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-06-22 16:11 (624 d 04:32 ago) @ mittyri Posting: # 20358 Views: 2,362 |
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Hi Mittyri, » » AFAIK this one is the most interesting. Authors are INSERM and FDA people. But it looks like their adaptive design cannot control TIE. How come? The devil is in the details. ![]() → type I error α1 (stage 1)=α2 (stage 2)=0.0304 to ensure global α 0.05 [7]. Though [7] lamented that Potvin used 0.0294 (which is Pocock’s α for a one-sided test and the right one for equivalence is 0.0304), they erred.
Furthermore, they performed 500 (‼) simulations for the type I error, … Quote:
— Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |