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Ohlbe ★★★ France, 2014-11-18 23:55 (3445 d 02:16 ago) Posting: # 13874 Views: 3,664 |
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— Regards Ohlbe |
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Ohlbe ★★★ France, 2014-11-27 20:22 (3436 d 05:49 ago) @ Ohlbe Posting: # 13938 Views: 2,815 |
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— Regards Ohlbe |
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kumarnaidu ★ Mumbai, India, 2014-11-28 07:20 (3435 d 18:50 ago) @ Ohlbe Posting: # 13939 Views: 2,800 |
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Thanks Ohlbe for sharing guidance. The date for coming into effect for this guidance is 1 June 2015. Can we submit the study as per the old guidance (without pAUC) now?  — Kumar Naidu |
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Ohlbe ★★★ France, 2014-11-28 10:30 (3435 d 15:41 ago) @ kumarnaidu Posting: # 13943 Views: 2,741 |
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Dear Kumar, ❝ The date for coming into effect for this guidance is 1 June 2015. Can we submit the study as per the old guidance (without pAUC) now? Yes. The old guideline still applies to any application submitted before this date. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2014-11-28 15:11 (3435 d 11:00 ago) @ Ohlbe Posting: # 13950 Views: 2,785 |
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Dear Ohlbe and Kumar, ❝ ❝ The date for coming into effect for this guidance is 1 June 2015. Can we submit the study as per the old guidance (without pAUC) now? ❝ ❝ Yes. The old guideline still applies to any application submitted before this date. In principle yes. But see my experiences with a study which was performed before the effective date (of the BMV-GL) but submitted after. @Kumar: In your case I would suggest to calculate pAUCs in an exploratory manner and – if the report is already finalized – submit it as an addendum. If you pass BE for these metrics, fine. If not, be prepared to answer questions (not foreseen in the protocol according to the “old” GL, not powered to show BE for these metrics,  ).PS: IMHO the GL is rather disappointing. Seems that the PKWP essentially didn’t care too much about comments and discussions at conferences. — 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 |
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Ohlbe ★★★ France, 2014-11-28 19:29 (3435 d 06:41 ago) @ Helmut Posting: # 13953 Views: 2,725 |
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Dear Helmut, ❝ In principle yes. But see my experiences with a study which was performed before the effective date (of the BMV-GL) but submitted after. Sure. That's why I wrote submitted before the effective date, not just performed before... — Regards Ohlbe |
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Jay ☆ India, 2014-12-01 12:11 (3432 d 13:59 ago) @ Ohlbe Posting: # 13960 Views: 2,721 |
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Dear all, As mentioned in the final guidelines, for prolonged release products, the partial AUC is required for those products with no risk of accumulation. As in draft GL, it was required by default for prolonged release products. So what would be the rational behind not determining pAUC for PR drugs products with accumulation. Also, to determine accumulation before study one either need to literature search or there would be compulsory requirement of pilot study. Suppose, the study designed who is designed on the basis of accumulation i.e. without pAUC and the results does show accumulation.  Would it be acceptable?Also regarding the truncation point for pAUC, in 6.1.1.2, "the half of the dosage interval are recommended" so can this be considered thumb rule for truncation of pAUC of PR Products.? Regards, Jay |
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nobody nothing 2014-12-01 16:48 (3432 d 09:22 ago) @ Jay Posting: # 13961 Views: 2,602 |
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Do these questions imply that you start a full MR program without any pilot for candidate formulation selections? Kind of shocking to me... How do you want to learn the PK of your MR-formulation from the literature? Just asking, I'm an idiot from Europe, have to learn a lot maybe... — Kindest regards, nobody |
Ing. Helmut Schütz