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Jana Zigova ☆ Slovakia, 2011-04-10 17:10 (5559 d 12:41 ago) Posting: # 6881 Views: 4,220 |
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In the reflection of revised CPMP/EWP/QWP/1401/98 guideline (Rev. 1/Corr*), I would appreciate your opinion on the case when bioequivalence is demonstrated in 12 subjects in Pilot BE Study and the stop criterion is specified in the Study Protocol prospectively. I suppose, that the status remains the same as it was presented on this Forum 2006-08-16 12:44 by Helmut (#218 BE demonstrated in pilot study). i.e.: ❝ It should be possible to claim BE with a pilot study, if ❝ 1.your sample size is at least the minimum required in the legislation you ❝ are bound to (e.g., 12 for WHO, EU, USA [?] CAN, NZ, AUS, Malaysia, Argentina, ❝ ASEAN States, RSA [20 for MR products]; 24 for Brazil), and ❝ 2.you have stated such a 'stop criterium' in your study protocol. What is your current view? Many thanks. Best regards, Jana |
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ElMaestro ★★★ Denmark, 2011-04-10 20:13 (5559 d 09:38 ago) @ Jana Zigova Posting: # 6882 Views: 3,551 |
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Hi, ❝ I would appreciate your opinion on the case when bioequivalence is demonstrated in 12 subjects in Pilot BE Study and the stop criterion is specified in the Study Protocol prospectively. it sounds to me like BE is demonstrated. I would submit it. — Pass or fail! ElMaestro |
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Dr_Dan ★★ Germany, 2011-04-11 11:56 (5558 d 17:54 ago) @ ElMaestro Posting: # 6883 Views: 3,403 |
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Hi I agree with ElMaestro but before you submit you should check if the test product used in the study is representative of the product to be marketed (see CPMP/QWP/EWP/1401/98 Rev. 1). If you used only a lab scale batch (as in general for pilot studies) you have to perform a pivotal BE study with a validation batch of the test product. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz