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sri ☆ 2008-02-28 09:04 (6691 d 20:55 ago) Posting: # 1638 Views: 5,874 |
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Dear all, for incurred sample analysis what are the time points recommended for analysis please refer me the guidelines as iam new to this field. |
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Ohlbe ★★★ France, 2008-02-28 11:08 (6691 d 18:51 ago) @ sri Posting: # 1640 Views: 5,039 |
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Dear Sri, There is currently no guideline on this topic, only lots of discussions. There was an AAPS two-day workshop recently on this topic, some of the slides have been put online and can be found here. It may already give you some ideas on the problem and proposals. Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2008-03-11 16:30 (6679 d 13:29 ago) @ Ohlbe Posting: # 1683 Views: 4,862 |
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Dear Ohlbe! ❝ [...] only lots of discussions. Though the requirement of 15% incurred samples was removed from the guidelines in 2003, Health Canada on 09 Jan 2008 published a Notice: Replication of Incurred Samples in Bioavailablity/Bioequivalence Studies requesting '[...] a voluntary submission of data collected on replicate samples since 2000. [...] This information will be used for research purposes only and will in no way affect past regulatory decisions. [...] Release of the information will be limited to summary statistics, with no linkage between the sponsor and the data.' HPB hopes '... to be able to present our findings at the next Canadian Workshop on Recent Issues in GLP Bioanalysis on April 17-18, 2008 in Montreal.' — 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, 2008-03-11 20:10 (6679 d 09:49 ago) @ Helmut Posting: # 1684 Views: 4,785 |
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Dear HS, ❝ HPB hopes '... to be able to present our findings at the next Canadian ❝ Workshop on Recent Issues in GLP Bioanalysis on April 17-18, 2008 in ❝ Montreal.' HPB are indeed the ones who have the more information available on incurred sample re-analysis ! Even though what they received in the past was probably biased as the data showing the more problems were probably never submitted. It is great to see that other authorities are also trying to make their own minds on this topic, not just following FDA or doing nothing at all. I hope some movement will start in Europe one day too. European industry have started to think about it through the European Bioanalysis Forum, but so far it seems they are only opened to pharma companies, not CROs, and I don't know if they have established contacts with European regulatory bodies. From what I have heard of the recent AAPS meeting, FDA was again very strict and not open to discussions. It seems that they would require incurred sample reanalysis for each BE trial, not just once for all trials at the same site with the same method. I can understand requiring it for patients and special populations in addition to healthy volunteers, but why it should be done for each and every BE study, all on healthy subjects, remains unclear to me. Regards Ohlbe |
Ing. Helmut Schütz