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ABP ☆ India, 2013-01-01 19:06 (4926 d 01:14 ago) Posting: # 9775 Views: 4,264 |
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Dear Sir, At the outset I wish each one of you a very Happy, Healthy and Prosperous New Year ahead.  I have one question about the study design. I would highly appreciate if you could help me understand the design issue for a FDA submission study. Can we have a different study design for fast and fed study in the same set of studies. For e.g. planning one of the studies as 3 WC and another one as 2 WC? If yes, then could you please explain the rational. Thanks in advance. Yours, ABP |
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Helmut ★★★   Vienna, Austria, 2013-01-01 19:31 (4926 d 00:48 ago) @ ABP Posting: # 9776 Views: 3,865 |
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Dear ABP! ❝ Dear Sir,
❝ […] Can we have a different study design for fast and fed study in the same set of studies. For e.g. planning one of the studies as 3 WC and another one as 2 WC? I hope by “n WC” you mean n-way cross-over? I would suggest to have a look at FDA’s 1000+ product-specific guidances first. ❝ If yes, then could you please explain the rational. I don’t know your rationale to run a three-way. Are you planning for two candidate test formulations versus the RLD? I don’t know whether FDA would like that. IMHO it is preferable to do the selection between the tests in a pilot study and perform the pivotal as a 2-way. Another possibility would be a single test versus the RLD (R1) and a European reference (R2). That’s acceptable (example: FDA wants both fasting/fed and EMA fasting only).
— 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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ABP ☆ India, 2013-01-03 12:44 (4924 d 07:35 ago) @ Helmut Posting: # 9781 Views: 3,498 |
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Dear Helmut, Thanks for the correction. I sincerely apologies for not addressing the mail to female members of the forum. I request them to please share their comments too on the query. THanks for your expert opinion on the query. However, as instructed to furnish some more details, the study is planned for FDA submission and seems to be on the basis of ISCV in two different meal status. One study is planned to be two way and one as three way. In three way study, the reference will be dosed twice and the test once. I hope this much information will help. Thanks and best regards ABP 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! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2013-01-03 13:27 (4924 d 06:52 ago) @ ABP Posting: # 9782 Views: 3,610 |
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Hi APB! ❝ […] the study […] seems to be on the basis of ISCV in two different meal status. One study is planned to be two way and one as three way. In three way study, the reference will be dosed twice and the test once. So you are expecting a CVintra >30% in the fed (?) study and want to go for RSABE. I don’t see any reason why the FDA should not accept such an approach. A warning: If you don’t have strong evidence that you deal with a HVD/HVDP (i.e., CVintra < ~40%) power the study for conventional ABE. If by chance the CV is <30% you are not allowed to scale. For details see FDA’s progesterone guidance. — 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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ABP ☆ India, 2013-01-09 09:01 (4918 d 11:19 ago) @ Helmut Posting: # 9800 Views: 2,696 |
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Dear Helmut, Thanks for the response. Regards ABP |
Ing. Helmut Schütz