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kumarnaidu ★ Mumbai, India, 2016-01-28 10:58 (3003 d 13:17 ago) Posting: # 15873 Views: 2,199 |
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Suppose a company have conducted one pilot study to access the suitability of the test product for the further pivotal BE evaluation and fortunately results of this pilot study has passed as per the EU regulatory acceptance criteria of 80-125 for all the parameters including partial AUCs. Does the EU Authority accept pilot study data with below mentioned loop holes for the registration of product? 1. This study lacks ISR 2. Do regulatory accept the ISR post statistic analysis? 3. The title of the study mention the word " Pilot study" Does anybody have an example of such regulatory authority approval or comments for such kind of submission? Awaited for your response. Regards, Kumar — Kumar Naidu |
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ElMaestro ★★★ Denmark, 2016-01-29 01:07 (3002 d 23:09 ago) @ kumarnaidu Posting: # 15888 Views: 1,695 |
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Hi kumarnaidu, I have been discussing this with regulators a few times. The opinions apparently differ between agencies and quite possibly also from regulator to regulator within specific agencies. The hardliners and most statisticians, like you indicate, will not accept it. The softliners will accept it on ethical grounds (it is almost unnecessary and unethical to test the stuff again if you know reasonably know the outcome). Lack of ISR is a showstopper however. I am not convinced that you can get easily away with it. It will require additional stability studies beforehand, won't it? For future purposes take a scientific advice. And pick your country for sc. advice and submission well - do not (and I really mean not) just pick the country where your EU subsidiary is headquartered or where the most important market is. — Pass or fail! ElMaestro |
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