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Dr Andrew Leary ★ Ireland, 2013-03-18 10:52 (4454 d 13:00 ago) Posting: # 10217 Views: 4,758 |
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Dear All I expect that many of you will have come across regulators who apply current bioanalytical guidelines to studies which were completed prior to 2011, without ISR. The PKWP Q&A document from 10 DEC 2012 suggests that scientific justification for the lack of ISR might include taking into consideration "the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability". Any ideas as to exactly how this might be achieved?  KR Andrew Leary |
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ElMaestro ★★★ Denmark, 2013-03-18 11:13 (4454 d 12:40 ago) @ Dr Andrew Leary Posting: # 10218 Views: 3,977 |
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Hi Andrew, ❝ Any ideas as to exactly how this might be achieved? I believe the sentence is a little gem in terms of wording. The regulators are basically asking you to prove that the data you did not generate are not a source of trouble. On one hand I think CMD(h) was a little tired of all the dossiers that were lacking ISR since they all caused trouble, on the other hand the working groups stuck to the ISR requirement. And thus they ended up with that very *cough* flexible wording. I believe a user on this forum quite elegantly said that regulators seemed to have found a way to specify an expiry date for studies from the past. Even though lack of ISR to the best of my knowledge has never been shown to be a real rather than perceived cause of concern I have no good idea how to justify the lack of ISR in view of the wording of the Q&A. If the working groups could give examples on when and how lack of ISR would be justified then I think that would be an excellent improvement to the Q&A. — Pass or fail! ElMaestro |
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Dr Andrew Leary ★ Ireland, 2013-03-18 14:02 (4454 d 09:51 ago) @ ElMaestro Posting: # 10223 Views: 3,894 |
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Many thanks, ElMaestro! It's one thing to view studies from 15 years ago as having passed their 'sell by' date, but quite another to have to throw out studies from only 3 or 4 years back. I'll 'watch this space' with interest.  KR Andrew |
Ing. Helmut Schütz