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swapnil.kuche ★ 2011-06-23 13:14 (5484 d 04:23 ago) Posting: # 7165 Views: 3,256 |
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Dear Helmut, Can you please clear following doubt of mine? On Home Page of BEBAC site the is reference given for EU-EMA Bioanlaytical Method Validation. When I access that particular guidline it is found to be (CPMP/ICH/381/95) ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology. But this guidlines is applicable for validation of anaytical methods though most of the terminilogies are same for analytical and bioanalytical validation. Is there any specific bioanaytical method validation GL is avilable from EU-EMA? Any initative from EU-EMA for developing bioanalytical specific GL Regards, Swapnil Kuche |
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Helmut ★★★   Vienna, Austria, 2011-06-23 14:57 (5484 d 02:40 ago) @ swapnil.kuche Posting: # 7166 Views: 2,692 |
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Dear Swapnil! ❝ Any initative from EU-EMA for developing bioanalytical specific GL Sure. See this post. The 2009 draft is linked at EMA’s documents – scroll down to the heading ‘○ Miscellaneous’. Finalisation is expected this year. — 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 |
Ing. Helmut Schütz