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talr ☆ Israel, 2008-11-09 17:11 (6441 d 08:43 ago) Posting: # 2643 Views: 4,805 |
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In case we will want to registered a 4mg or 5 mg drug product that was registered for adults - as a product for children, and we had performed a successful BE study in adults: will we be required to perform a Bio equivalent study also in children? thanks in advance for help, Talr |
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JPL ☆ Vienna, 2008-11-10 10:58 (6440 d 14:56 ago) @ talr Posting: # 2646 Views: 4,290 |
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Dear talr, I guess you refer to montelukast sodium, which is on the market for children > 12 months of 4mg dosed tablet. So, is it a different application form you're intrested in? Regards, JPL |
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talr ☆ Israel, 2008-11-10 11:16 (6440 d 14:38 ago) (edited on 2008-11-10 11:45) @ JPL Posting: # 2647 Views: 4,236 |
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Dear JPL, Yes I mean a similar drug to Singulair granules 4 mg that is marketed for children. The application will be similar. the question was if we have done a bioequivalence study in adults, comparing tabelts, will it be sufficient to support the launching of a 4 mg granules in sachets, or will the authorities ask us to perform a bioequivalence study with the reference as granules as well Thanks -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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JPL ☆ Vienna, 2008-11-13 16:02 (6437 d 09:53 ago) @ talr Posting: # 2667 Views: 4,260 |
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Dear talr, I guess you have to conduct a BE-study in children with the marketed formulation as reference as long as you don't get a biowaiver. regards, JPL |
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Ohlbe ★★★ France, 2008-11-13 16:42 (6437 d 09:12 ago) @ JPL Posting: # 2668 Views: 4,280 |
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Dear JPL and talr, I have never seen, or heard of, a BE study in children so far, even for drugs intended to be given to kids. I can't tell about other markets, but the current EU BE guideline recommends to run the trial in subjects 18 to 55 years old. Same for the draft guideline. All I've ever seen asked to be done in children was an acceptability study, in the case of oral solutions or suspensions, when the active substance was known to have a very bad taste. If you have already done a study in adults on your formulation, or if you can ask for a waiver based on a study on a higher strength + proportional composition + PK linearity, you should not need to run a new trial. In case of doubt ask the regulators in the country where you intend to make your application. Anyway you would probably have a hard time finding a CRO ready to run a BE trial in children, and an Ethics Committee ready to approve it. Regards Ohlbe |
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talr ☆ Israel, 2008-11-15 13:54 (6435 d 12:00 ago) @ Ohlbe Posting: # 2675 Views: 4,011 |
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Thanks alot, Just to let you know, We got a letter from ministry of health in Israel, saying that in the future, every submission for a drug for use in children, will have to be supported with a bio study in the age group. That was a general message and that allow the authorities to demand that additional clinical studies at any stage of the license application. But from what I read, the opinion are not totaly settled in EU, Thanks talr |
Ing. Helmut Schütz