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Clarc ☆  Romania, 2013-10-18 13:11 (4632 d 11:07 ago) Posting: # 11693 Views: 4,935 |
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Hi all My problem is related to a generic, whose reference product is 25, 50 and 100 mg. The sponsor however wants to formulate a 35 and 70 mg generic (saying that this way is more effective...??? - I don't want to argue with them...). Is there a way to obtain approval for the test product based only on bioequivalence? If yes, what kind of design should we use? Thanks in advance. — I'm always tryin' to do something new, tryin' to look like a beginner. Meshell Ndegeocello |
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jag009 ★★★ NJ, 2013-10-18 16:59 (4632 d 07:19 ago) @ Clarc Posting: # 11701 Views: 4,345 |
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Hi, ❝ Is there a way to obtain approval for the test product based only on bioequivalence? If yes, what kind of design should we use? Why not just file a notification to the agency and get an answer first? Better to ask before throwing money away. John |
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Clarc ☆ Romania, 2013-10-18 17:10 (4632 d 07:08 ago) @ jag009 Posting: # 11703 Views: 4,316 |
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Thanks John ❝ Why not just file a notification to the agency and get an answer first? Better to ask before throwing money away. ❝ — I'm always tryin' to do something new, tryin' to look like a beginner. Meshell Ndegeocello |
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jag009 ★★★ NJ, 2013-10-21 17:49 (4629 d 06:29 ago) @ Clarc Posting: # 11721 Views: 4,164 |
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Hi, ❝ I agree that it's better to ask... however I was hoping someone has dealt with this or some similar situation already... Search a previous post (look for keyword Nifedipine). I think Luvbloom (one of the members here) did something similar before for a dose that is lower than the dose of the reference listed drug). John |
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ElMaestro ★★★ Denmark, 2013-10-18 17:29 (4632 d 06:49 ago) @ Clarc Posting: # 11704 Views: 4,361 |
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Hi Clarc, ❝ generic (...) more effective (...) bioequivalence? These terms are almost mutually exclusive. If you target USA then it will be a 505(b)(2) and if you are targeting EU then it will be a 10.3. Not generic. If the claim is to make the drug 'more effective' then BE or TE is not the aim of the pivotal trial - you will be looking at superiority. — Pass or fail! ElMaestro |
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Clarc ☆ Romania, 2013-10-21 10:01 (4629 d 14:17 ago) @ ElMaestro Posting: # 11713 Views: 4,167 |
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Thank You ElMaestro ❝ If you target USA then it will be a 505(b)(2) and if you are targeting EU then it will be a 10.3. Not generic. If the claim is to make the drug 'more effective' then BE or TE is not the aim of the pivotal trial - you will be looking at superiority. The sponsor only say that it is more effective using this strength, but does not want to prove it, so the claim is not to make the drug more effective, but to have a different strength on the market. However You were right about the 10.3., this is the way they should go with it. Thanks again. Clarc  — I'm always tryin' to do something new, tryin' to look like a beginner. Meshell Ndegeocello |
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Clarc ☆ Romania, 2013-10-21 12:45 (4629 d 11:33 ago) @ Clarc Posting: # 11715 Views: 4,221 |
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Dear all After going through a lot of documents and guides, I've understood that in these cases, three different studies should be conducted to assess the pharmacokinetics of the newly formulated (new strength) drug. The absolute bioavailability, food effects and dose proportionality have to be determined. Since there is already a publicated study in this regard, performed on the original product, do You think is it possible to skip the absolute-BA or/and the food effect, or there is a need to perform all three of them? Would it make sense to think about performing a dose proportionality test between the 70 mg test and the 100 mg reference, or would it make sense to develop a 100 mg test, perform a bioequivalence trial for the 100 mg strength, and after this bioequivalence is demonstrated, the 35 mg and 70 mg strength to be submitted, based on a dose proportionality studty??? Thanks — I'm always tryin' to do something new, tryin' to look like a beginner. Meshell Ndegeocello |
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jag009 ★★★ NJ, 2013-10-21 19:53 (4629 d 04:25 ago) @ Clarc Posting: # 11722 Views: 4,227 |
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Hi, ❝ Since there is already a publicated study in this regard, performed on the original product, do You think is it possible to skip the absolute-BA or/and the food effect, or there is a need to perform all three of them? ❝ Would it make sense to think about performing a dose proportionality test between the 70 mg test and the 100 mg reference, or would it make sense to develop a 100 mg test, perform a bioequivalence trial for the 100 mg strength, and after this bioequivalence is demonstrated, the 35 mg and 70 mg strength to be submitted, based on a dose proportionality studty??? That's a bit monumental for developing a "middle" strength(s) generic of a product, don't you think? This might be out of line but what is the benefit of 35 and 70 mg strengths of your client's product? John |
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Clarc ☆ Romania, 2013-10-24 15:06 (4626 d 09:12 ago) @ jag009 Posting: # 11747 Views: 4,093 |
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Thanks John for all the advices ❝ That's a bit monumental for developing a "middle" strength(s) generic of a product, don't you think? This might be out of line but what is the benefit of 35 and 70 mg strengths of your client's product? Yes it can be monumental, however if the sponsor can afford it, I'm not questioning his will.  Now seriously: the sponsor performed some clinical trials (not in EU) and they concluded that the 35 mg test has the same clinical efficiency as the 50 mg reference. The same applies to the 70 mg vs. the 100 mg reference. If this is true, than this middle strength generic will be better tolerated by the patient (think on AE's, and of course on the price too), and the better (anticipated) compliance will make it much more cost-effective versus the concurrent generics. (....my guess) — I'm always tryin' to do something new, tryin' to look like a beginner. Meshell Ndegeocello |
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jag009 ★★★ NJ, 2013-10-24 17:47 (4626 d 06:31 ago) @ Clarc Posting: # 11752 Views: 4,102 |
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Hi, I agree with ElMaestro. If that's the case then you should discuss with your client to file a 10.3 (for me, FDA = 505(b)2). I don't understand why your sponsor wants generic in such a scenario since he already has clinical data supporting a product with a lower strength having similar efficacy of a higher strength (ok it wasn't done in EU so may not be useful). (In USA) you can file a (b)2 by showing BE to the higher strength (i.e., 35 mg BE to 50 mg) and claiming equivalent efficacy ((b)2 without clinical). My old company did this before and I know a few others have done it too. It's a much better route than going generic (money wise in terms of profit). But if you want to go through the BE route then I don't know how you can do it... John |
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ElMaestro ★★★ Denmark, 2013-10-25 01:05 (4625 d 23:13 ago) @ Clarc Posting: # 11761 Views: 4,061 |
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Hi Clarc, ❝ Now seriously: the sponsor performed some clinical trials (not in EU) and they concluded that the 35 mg test has the same clinical efficiency as the 50 mg reference. The same applies to the 70 mg vs. the 100 mg reference. If this is true, than this middle strength generic will be better tolerated by the patient (think on AE's, and of course on the price too), and the better (anticipated) compliance will make it much more cost-effective versus the concurrent generics. (....my guess) I have a feeling that the devil is in the details. Was 35T, 50R, 70T, 100R tested in the same study? Are you able to prove a dose-response if asked to elaborate on the claim that 35T~50R and so forth. Why would you do a trial with a clinical endpoint if aiming for an EU 10.1 where BE is tightly linked specifically to PK? — Pass or fail! ElMaestro |
Ing. Helmut Schütz