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chidambarajoshi ★ Hyderabad-INDIA, 2008-09-02 08:19 (6503 d 00:11 ago) Posting: # 2297 Views: 5,891 |
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Dear all, At the time of validation if matrix used is a mimic of samples to be analyzed is there any necessity of Incurred sample reanalysis? Regards, Joshi — Best Regards Joshi |
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Ohlbe ★★★ France, 2008-09-02 17:29 (6502 d 15:01 ago) @ chidambarajoshi Posting: # 2305 Views: 4,902 |
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Dear Joshi, ❝ At the time of validation if matrix used is a mimic of samples to be analyzed This would mean that you would be performing your validation with samples from a previous study ? Basically, you would be doing this incurred samples re-analysis for one study, and using this for other studies on the same drug. Difficult to say if the FDA (as far as I know, they are the only ones asking for incurred samples re-analysis so far) would accept it or not: they have not incorporated this into a guideline so far. But from what I have heard of the AAPS meeting on incurred samples reanalysis last February or March, they were willing to ask for it for each and every BE trial. They might accept it for other kind of trials. Don't pretend to "mimic" real samples another way. You would spend more time trying to convince the FDA that your samples are representative of study samples. One prerequisite would be that your drug has strictly no metabolite; other possible sources of variation would be more problematic to discuss. Regards Ohlbe |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-09-04 09:07 (6500 d 23:23 ago) @ Ohlbe Posting: # 2312 Views: 4,893 |
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Dear Ohlbe Thanks for the reply. ❝ They might accept it for other kind of trials. Yes! my question was not only related to BE study but also for Phase II trial. As for BE study is concerned FDA may not be convinced. Regards, Joshi — Best Regards Joshi |
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han16 ● 2009-02-17 12:40 (6334 d 18:50 ago) @ Ohlbe Posting: # 3256 Views: 4,585 |
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Dear Ohlbe, I have a question, that is now a days everyone is opting for incurred samples reanalysis (ISR), and preparing their own in house Standard Operating Procedures for the same, everything looks good if the results obtained after incurred samples reanalysis are within the limits but in case if the results of the samples deviate from the acceptance criteria, for example the whole batch got failed, then you may say anyway ISR is selected from the duplicate samples thus sample volume is available,in a case where no sample volume available for example pre-clinical PK samples then how are we going to address the issue. Please guide.  Thanking you in advance |
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Ohlbe ★★★ France, 2009-02-17 21:39 (6334 d 09:51 ago) @ han16 Posting: # 3268 Views: 4,447 |
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Dear han16, ❝ in a case where no sample volume available for example pre-clinical PK ❝ samples then how are we going to address the issue. This is indeed a difficult situation. In preclinical studies you usually have low sample volumes (50 µl in mice is already quite good). This was one of the objections raised by Industry at that Crystal City meeting in 2006, and the FDA didn't give a solution. But at least for preclinical they don't ask for incurred samples reanalysis for each and every study. You can do it just once for each species. For BE studies you have usually more sample volume. And even if one batch fails, you will have samples remaining from other subjects to do the incurred samples re-analysis. Regards Ohlbe — Regards Ohlbe |
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han16 ● 2009-02-18 11:28 (6333 d 20:02 ago) @ Ohlbe Posting: # 3269 Views: 4,382 |
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Thank you Ohlbe |
Ing. Helmut Schütz