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sushilsingh ● 2007-08-27 08:07 (6879 d 08:48 ago) (edited on 2007-08-27 11:10) Posting: # 1024 Views: 5,650 |
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Can anyone perform BA studies under ANDA kind of scenario. For eg if we want to test the bioavailability of five test formulation (single period BA study on 30 vol.) to check which one is giving better profile. Subsequently the best two will be picked up for conducting routine BE pilot study. What is the rationale (ethical as well as scientific) of this kind of study. Provide your expert comment on it. [edit] Capitals changed to mixed case. Please read the forum policy/instructions for use ! [Ohlbe] |
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Ohlbe ★★★ France, 2007-08-27 13:17 (6879 d 03:39 ago) @ sushilsingh Posting: # 1025 Views: 4,520 |
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Dear sushilsingh, Welcome to the BEBAC forum. Please read the Forum's policy/instructions for use ! 1. avoid using only capital letters. Capital letters mean that you are SCREAMING. The use of only capital letters is considered as rude on any forum. 2. starting a post with a salutation, and ending with a signature, is encouraged. 3. please use a more specific title for your post. These tips increase your chances of getting an answer. Regards Ohlbe |
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sushilsingh ● 2007-08-27 16:18 (6879 d 00:38 ago) @ Ohlbe Posting: # 1032 Views: 4,452 |
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Dear Ohlbe, Kindly clarify Parallel groups "pilot pilot" study. (Any reference) Regards Sushil |
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Ohlbe ★★★ France, 2007-08-27 16:45 (6879 d 00:10 ago) @ sushilsingh Posting: # 1033 Views: 4,547 |
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Dear Sushil, ❝ Kindly clarify Parallel groups "pilot pilot" study. (Any reference) This is how I would summarise your question: you mention running a single-period BA trial on 5 formulations, meaning this would be parallel groups. You mention that you would later be running a "routine BE pilot study". Meaning that the first one would be a pre-pilot, or pilot-pilot (the name is mine, I have no reference to give). Did I understand it wrong ? Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2007-08-27 16:57 (6878 d 23:58 ago) @ sushilsingh Posting: # 1034 Views: 4,545 |
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Dear Sushil, just adding some comments to Ohlbe's post. I came to exactly his conclusions from your original post. ❝ ... to check which one is giving better profile. Subsequently the best two ❝ will be picked up for conducting routine BE pilot study. Please define 'better/best'. Since you have no reference in your setting, IMHO you simply have no idea how the reference performes - or do you want to compare with literature? ❝ What is the rationale (ethical as well as scientific) of this kind of study.  — 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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sushilsingh ● 2007-08-28 16:26 (6878 d 00:29 ago) @ Helmut Posting: # 1035 Views: 4,344 |
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❝ Since you have no reference in your setting, IMHO you simply have no idea ❝ how the reference performes - or do you want to compare with literature? Yes comparison will be done with the literature. ❝ ❝ What is the rationale (ethical as well as scientific) of this kind of ❝ ❝ study. Is it ethical to conduct BA study on healty volunteers just to come out with best test product?  In my small tenure in BA/BE field i never came across such type of study design.IMHO establishing IVIVC can only be the scientific rationale of such type of study (For eg class II drugs in respect to Biopharmaceutics Classification System). If i am wrong please correct me. Regards, Sushil |
Ing. Helmut Schütz