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Pankaj ☆ India, 2010-03-21 17:30 (5939 d 05:12 ago) Posting: # 4950 Views: 4,542 |
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Dear All, Planning to design a BABE protocol on a molecule with Tmax around 1-1.5 hours and T-half of around 550 hours. Can we go for parallel truncated design for the molecule? Does all the regulatories (US/EU/ANVISA) accept such kind of design for BABE studies? Kindly Suggest. Thanks in advance. Regards, Pankaj |
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Helmut ★★★   Vienna, Austria, 2010-03-22 07:33 (5938 d 15:09 ago) @ Pankaj Posting: # 4952 Views: 4,036 |
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Dear Pankaj! ❝ Planning to design a BABE protocol on a molecule with Tmax around 1-1.5 ❝ hours and T-half of around 550 hours. ❝ Can we go for parallel truncated design for the molecule? Does all the ❝ regulatories (US/EU/ANVISA) accept such kind of design for BABE studies? If you sample for 72 hours: EU/EMA: Yes US/FDA: Yes, but only if 'low intrasubject variability in distribution and clearance' demonstrated,  Brazil/ANIVSA: Yes TGD/Canada: like US ... any many others. Why didn't you do your homework fist and look it up in the Guidance page? — 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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Pankaj ☆ India, 2010-03-22 08:17 (5938 d 14:25 ago) (edited on 2010-03-22 09:51) @ Helmut Posting: # 4953 Views: 3,719 |
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Dear HS, Thanks for the prompt response. I was aware of both Parallel and Truncated design individually. But wasn't sure whether I can club Parallel with truncation model since it is not clearly mentioned in the guidelines. Please correct me if I am wrong. Regards, Pankaj Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Helmut ★★★ Vienna, Austria, 2010-03-22 15:43 (5938 d 06:59 ago) @ Pankaj Posting: # 4957 Views: 3,701 |
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Dear Pankaj! ❝ I was aware of both Parallel and Truncated design individually. But wasn't ❝ sure whether I can club Parallel with truncation model since it is not ❝ clearly mentioned in the guidelines. Ok, let's say it the other way 'round. Why did you think that one may not combine a parallel design with truncated AUC? I would say it's important to comprehend the 'sprit' (if any) behind guidelines and not to search all the time for a 100 % literally match with you intended design. The main reasons for a parallel design are quite clearly stated in GLs and I don't repeat them here. Truncated AUC helps in preventing drop-outs due to long sampling (or just missing samples). One might even get a better estimate of Cmax, since with the savings in budget, more frequent sampling in the earlier part of the profile becomes affordable. — 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 |
Ing. Helmut Schütz