Log in
Register|
talr ☆ Israel, 2008-10-14 19:18 (5670 d 21:30 ago) Posting: # 2530 Views: 4,611 |
|
|
I am very new on this forum, working as R&D manager in israel drug manufacturer (www.cts.co.il) And have a general question: is there any expirience in performing bioequivalence study of tablets versus solutions or sirups? Besides of the technical issue is there a regulatory reference to this question. I will be very gratefull to yuor answer, Best regards, Tali |
|
Helmut ★★★   Vienna, Austria, 2008-10-14 21:55 (5670 d 18:53 ago) @ talr Posting: # 2533 Views: 3,967 |
|
|
Dear Tali! ❝ is there any expirience in performing bioequivalence study of tablets ❝ versus solutions or sirups? Yes and no. Bioequivalence implies formulations which are pharmaceutical equivalents (IR tablet vs. IR tablet) or pharmaceutical alternatives (IR tablet vs. IR capsule). If there is no suitable reference marketed, you may want to assess the Relative Bioavailability: tablet vs. solution, or if no solution can be obtained, a suspension. For a definition of terms see the European Note for Guidance (Sections 2.3 and 2.4). ❝ Besides of the technical issue is there a regulatory reference to this ❝ question. This depends on the rationale of the study. In product development of MR it's not uncommon to run in vivo studies with a solution as a reference in order to obtain the in vivo input function. If you want to go for an abbreviated market authorisation (=generic product), a solution will not do the job! — 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 |
|
talr ☆ Israel, 2008-10-14 23:23 (5670 d 17:24 ago) @ Helmut Posting: # 2534 Views: 3,860 |
|
|
Thank you Dear Helmut for answer. Indeed I read the section 2.3 and 2.4 cerfully and I think that you stated the dilema very clearly: just to clearify: The product in development is a liquid dosage form for children or adults with swallowing difficulties, that is developed to be a substitute to the tablets of the same drug that are on the market, And the goal is to define the product as generic - but from your input I have the impression that such a comperative study, even if it will give a nice coralation will not be accepted as the only in vivo study for the drug product Can you explaim please the term "product development of MR" Thanks very much |
|
Helmut ★★★ Vienna, Austria, 2008-10-15 15:41 (5670 d 01:07 ago) @ talr Posting: # 2535 Views: 3,834 |
|
|
Dear Tali! ❝ The product in development is a liquid dosage form for children or adults ❝ with swallowing difficulties, that is developed to be a substitute to the ❝ tablets of the same drug that are on the market, ❝ And the goal is to define the product as generic - but from your input I ❝ have the impression that such a comperative study, even if it will give a ❝ nice coralation will not be accepted as the only in vivo study for the ❝ drug product Unfortunatelly I have no experience with Israel's guidelines and can only refer to European practices. Your case is covered in Section '5.1.2 Oral solutions': 'In those cases where an oral solution has to be tested against an oral immediate release formulation a comparative bioavailability study will be required unless an exemption can be justified (see 5.1.1).' Depending on the pharmacological profile of the drug Cmax may be an issue; I would recommend to go for a Scientific Advice with the competent authority. ❝ Can you explaim please the term "product development of MR" MR stands for 'Modified Release'. It's quite common to perform biostudies of development batches against oral solutions in order to obtain some kind of in vivo in vivo correlation (IVIVC). Nothing you have to worry about in your case... — 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 |
|
talr ☆ Israel, 2008-10-15 22:30 (5669 d 18:18 ago) @ Helmut Posting: # 2538 Views: 3,709 |
|
|
Dear Helmut. Thanks again. your answers are clarifying the fact that in the absence of "common" base for comparison between reference to developed product: clinical data will be required in order to assure the similarity. As for ❝ Unfortunatelly I have no experience with Israel's guidelines and can only ❝ refer to European practices. Israel's guidlines if complete adoption of EU directive, nevertheless minor changes sometimes are adopted in a specific case  I presented today the forum and our subject of "solution vs IR in the EU" to my managment and everyone were highly impressed by the professional support in this forum. Very well done! helmut and everyone here. Best regards, Tali |
|
Helmut ★★★ Vienna, Austria, 2008-10-16 00:14 (5669 d 16:33 ago) @ talr Posting: # 2539 Views: 3,975 |
|
|
Dear Tali, thanks for the  !❝ Israel's guidlines if complete adoption of EU directive, ❝ nevertheless minor changes sometimes are adopted in a specific case Do you have a link which I can add to the Guidance page? The English site http://www.health.gov.il/english/ soon ends up in Hebrew; once a document is found it's not that difficult to handle (thanks to google translate), but navigating the site whithout knowing Ivrit is extremely difficult - that's why I probably missed the BE-guideline... — 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