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Nirali ★ India, 2007-11-22 09:10 (6788 d 07:11 ago) Posting: # 1321 Views: 16,064 |
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Dear Friends, What is the minimum sample size required for Rabeprazole Bioequivalence study? Is Rabeprazole Highly Variable Drug (HVD)? Inter-Subject variability is more than 50%? I would be thankful to you if you share your exp. of Rabeprazole Bioequivalence study. Thanks & Regards, Nirali Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2007-11-23 18:27 (6786 d 21:53 ago) @ Nirali Posting: # 1327 Views: 12,897 |
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Dear Nirali! ❝ Is Rabeprazole Highly Variable Drug (HVD)? ❝ Inter-Subject variability is more than 50%? Most likely not. See these two references (both on single dose of 20mg):
— 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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Srinetram ☆ India, 2010-07-26 12:46 (5811 d 04:34 ago) @ Helmut Posting: # 5673 Views: 11,494 |
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Dear HS, Nirali and others ❝ ❝ Is Rabeprazole Highly Variable Drug (HVD)? ❝ ❝ Inter-Subject variability is more than 50%? Most likely Yes. In a (pilot) BE study with RABE in 18 volunteers the figures were: for AUC CVintra ~ 38% CVinter ~ 58% for Cmax CVintra ~ 67% CVinter ~ 76% software used: Winnonlin Besides, we have tried one partial replicate too and the CVintra ~ 42% for reference. So yes!!! It is most likely a HVD. Besides when we compared the Cmax values from different studies, it varied from 300-1000 ng/ml (mean values)  It looks like HVD!!!!!!Edit: Subject line changed to reflect content of post. [Helmut] |
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MGR ★ India, 2007-11-26 07:47 (6784 d 08:34 ago) @ Nirali Posting: # 1329 Views: 12,650 |
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Dear Nirali, Rabeprazole is not an HVD. But it belongs to the prazole family (light sensitive drug), we have to take care that the study must me done in yellow monochromatic light for good results. Regards, MGR — Regards, MGR |
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Dr Andrew Leary ★ Ireland, 2010-07-23 16:50 (5814 d 00:30 ago) @ MGR Posting: # 5666 Views: 11,433 |
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Dear All Any advances on this advice from 2007? I know the published BE studies are small, but see from the web that (a) according to Pharsight, rabeprazole has intra-subject CVs of 40% to 50%, and (b) Mylan used 72 subjects for their pivotal BE studies. Regards to all Andrew |
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Helmut ★★★ Vienna, Austria, 2010-07-24 16:05 (5813 d 01:16 ago) @ Dr Andrew Leary Posting: # 5669 Views: 11,410 |
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Dear Andrew, nice to read you again! ❝ […] but see from the web that (a) according to Pharsight, rabeprazole has intra-subject CVs of 40% to 50%, … Do you mean this one? Would be interesting where they got the data from… ❝ … and (b) Mylan used 72 subjects for their pivotal BE studies. Do you mean this one listed at ClinTrials? I’m not sure whether 72 is the final subject number, but the number of volunteers to be enrolled. Mylan’s list of completed studies don’t show the results… — 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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Pavidus ● 2010-07-26 10:06 (5811 d 07:14 ago) @ Dr Andrew Leary Posting: # 5671 Views: 11,416 |
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Dear Dr A Leary and all, in a (pilot) BE study with RABE in 14 volunteers the figures were: ▓▓▓▓▓▓▓▓▓▓▓▓ software used: Kinetica formulas used: CVintra SQRT(EXP(MSE)-1) CVinter SQRT(EXP((MSsubj(seq) - MSE)/2)-1) Hope this info provides you with some helpful hints... KR, P. Edit: Deleted information considered proprietary by Pavidus' employer (2010-12-08). [Helmut] |
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Dr Andrew Leary ★ Ireland, 2010-07-26 11:41 (5811 d 05:39 ago) @ Pavidus Posting: # 5672 Views: 11,391 |
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Pavidus, Helmut Many thanks for your comments and data. As you say, who knows where Pharsight came up with their numbers. I had also noted that Mylan have not posted the results of their study; furthermore, they do not market Rabeprazole. Perhaps they killed the project prior to the study going ahead. Nice to see some real data; very helpful. Enjoy what's left of the summer! Kind regards Andrew |
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Helmut ★★★ Vienna, Austria, 2010-07-26 14:47 (5811 d 02:33 ago) @ Dr Andrew Leary Posting: # 5674 Views: 11,321 |
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Dear Andrew! ❝ Pavidus, Helmut Though my Latin is a little bit rusty, “pavidus” makes a funny salutation. Edit: Oh, I see that you were referring to User Pavidus. ❝ Enjoy what's left of the summer! Yep, let’s see. Getting cooler after the 36 ℃ we had the last weeks.  Servus from Vienna (Vindobona) — 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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Dr Andrew Leary ★ Ireland, 2010-07-26 15:05 (5811 d 02:15 ago) @ Helmut Posting: # 5675 Views: 11,284 |
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Not sure what "pavidus" means; my Latin is so rusty it has fused. On the other hand, I see from Google that Pavidus is a Progressive Death Metal band from North West Ohio.  |
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Helmut ★★★ Vienna, Austria, 2010-07-26 15:26 (5811 d 01:54 ago) @ Dr Andrew Leary Posting: # 5676 Views: 11,324 |
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Hi Andrew! ❝ Not sure what "pavidus" means; my Latin is so rusty it has fused. Pavidus: trembling, quaking, fearful, timid, timorous, shy — 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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Pavidus ● 2010-07-26 17:41 (5810 d 23:40 ago) @ Dr Andrew Leary Posting: # 5682 Views: 11,303 |
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Oh no, no METAL, please .... I would be happy with PAVIDUS as: bescheiden meek sober humble modest decent frugal moderate diffident unassuming unboastful unobtrusive unpretentious self-deprecating douce [Scot.: modest] KR,P. |
Ing. Helmut Schütz