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AKV ☆ 2010-12-02 07:18 (5681 d 19:10 ago) Posting: # 6264 Views: 4,573 |
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Can any body guide me about the requirements of the extent of the bioanalytical method validation experiments required for performing Project sample analysis using commercially available kits. I have read about this in the following reference. The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis, European Bioanalysis Forum, 2nd Annual Open Symposium Hisperia Towers, Barcelona, Spain, 2-4 December 2009 I want to know about the regulatory requirements while validating a method using commercial kits which can further be used during Project Sample Analysis for a clinical study intended for regulatory submission. Edit: Conference report. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2010-12-02 14:35 (5681 d 11:53 ago) @ AKV Posting: # 6265 Views: 3,508 |
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Dear AKV, please see the Policy.  Current guidelines (and the EU draft as well) make no distinction between commercial kits and in-house LBAs. You have to fulfil the usual requirements (accuracy, precision, stability, cross-reactivity,  ).— 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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AKV ☆ 2010-12-03 07:27 (5680 d 19:01 ago) @ Helmut Posting: # 6266 Views: 3,571 |
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Dear Sir, I sincerely apologize for missing the basic requirements for posting a query to the forum. Due care will be taken henceforth. Many thanks for replying to the query. Regards |
Ing. Helmut Schütz