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Rajdeep ★ New Delhi, India, 2007-11-05 08:17 (6813 d 05:39 ago) Posting: # 1280 Views: 7,201 |
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Dear All I would hereby like to know what are the various types of study already done upon this molecule. If anyone can kindly provide me a list of some articles describing correct parameters to be followed in designing a study design for the above study. regards Rajdeep. — Best regards Rajdeep Mukherjee Protocol Developer |
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Helmut ★★★   Vienna, Austria, 2007-11-05 11:41 (6813 d 02:16 ago) @ Rajdeep Posting: # 1281 Views: 6,508 |
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Dear Rajdeep, according to FDA's recommendation the design should be pretty straightforward; do you have anything particular in mind which might complicate the design? — 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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Rajdeep ★ New Delhi, India, 2007-11-05 12:46 (6813 d 01:10 ago) @ Helmut Posting: # 1282 Views: 6,196 |
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❝ ... do you have anything particular in mind which might complicate ❝ the design? Dear Sir The particular thing which I am worried about is the effect of the non-linear pharmacokinetics of Voriconazole that might upset the design. So the question is whether there might be suitable parameters that can be followed inorder to cut-down the above variation in the study trial. That's the thing that makes me ask for similar articles featuring a study design on the above drug. regards Rajdeep. -- Edit: Full quote removed. Please see this post! [HS] — Best regards Rajdeep Mukherjee Protocol Developer |
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Helmut ★★★ Vienna, Austria, 2007-11-05 13:14 (6813 d 00:42 ago) @ Rajdeep Posting: # 1283 Views: 6,629 |
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Dear Rajdeep! ❝ ... non-linear pharmacokinetics of Voriconazole that might upset the design. ❝ So the question is whether there might be suitable parameters that can be ❝ followed inorder to cut-down the above variation in the study trial. It's a misconception that non-linear PK is connected to within-subject variability. Non-linear PK in the context of BE only means, that you will not get a biowaiver and have to show in vivo BE at least for the lowest and highest strengths. ❝ That's the thing that makes me ask for similar articles featuring a study ❝ design on the above drug. The only article I could find [1] deals with a multiple dose design, which is not acceptable to demonstrate BE in most regulations.CVintra was 14.7% for AUC0-12, and 17.1% for Cmax. Of course higher variability is expected after a single dose...
— 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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Rajdeep ★ New Delhi, India, 2007-11-05 13:31 (6813 d 00:25 ago) @ Helmut Posting: # 1284 Views: 6,244 |
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Dear Helmut Thanks a ton for your perspective. Actually I had already downloaded this multiple dose study. And as I guess you were right too in quoting me the same link. cheers Rajdeep -- Edit: Full quote removed. Please see this post! [Jaime] — Best regards Rajdeep Mukherjee Protocol Developer |
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Jaime_R ★★ Barcelona, 2007-11-05 13:49 (6813 d 00:07 ago) @ Rajdeep Posting: # 1285 Views: 6,096 |
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Hi Rajdeep! ❝ I would hereby like to know what are the various types of study already ❝ done upon this molecule. Do you want to perform a bioavalability study as the subject line suggests (which type: absolute, relative, comparative) or a bioequivalence study (as Helmut assumed)? — Regards, Jaime |
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Rajdeep ★ New Delhi, India, 2007-11-06 07:56 (6812 d 06:00 ago) (edited on 2007-11-07 11:46) @ Jaime_R Posting: # 1287 Views: 6,927 |
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Hi Jaime Well. As you see I will be preparing a protocol for a Voriconazole BA study. If you have any other inputs do let me know regards Rajdeep -- Edit: Full quote removed. Please see this post! [Jaime] — Best regards Rajdeep Mukherjee Protocol Developer |
Ing. Helmut Schütz