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09:38 Jan 25, 2010 |
German to English translations [PRO] Science - Other | |||||||
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| Selected response from: Marga Shaw United Kingdom Local time: 13:31 | ||||||
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Summary of answers provided | ||||
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2 +2 | release panel |
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3 | approval panel |
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release panel Explanation: "ELISA release panel" A new FDA lot release panel for antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I Release Panel 1) is now available for distribution by the Center for Biologics Evaluation and Research, FDA. The purpose of Panel 1 is for the qualitative and semi-qualitative evaluation of in vitro tests to detect antibody to HTLV-I in human serum or plasma. It is a regulatory panel similar to the HTLV-III Reference Panel 2. The HTLV-I Release Panel 1 is designed to provide a release criterion for lots of HTLV-I antibody detection kits produced by licensed manufacturer or lots of produced by manufacturers pursuing licensure of such tests and should not be used for experimental or other reference purposes. Due to the expected large number of requests for this panel, Center for Biologics Evaluation and Research will limit the distribution of the panel when necessary. http://docs.google.com/viewer?a=v&q=cache:MZwrXjNVhU8J:www.f... -------------------------------------------------- Note added at 25 mins (2010-01-25 10:03:15 GMT) -------------------------------------------------- Lot Release Panel to test lot to lot consistency CBER Lot Release Panel developed http://209.85.229.132/search?q=cache:DNmIQRE9bSgJ:www.who.in... -------------------------------------------------- Note added at 38 mins (2010-01-25 10:17:13 GMT) -------------------------------------------------- Manufacturing controls * Aim is to minimize within-serial and serial-to-serial variation by ensuring consistency of production – Outline of Production * Master Seed/Master Cell concept * Validation of new lots of antibody/antisera * Serial release testing of serum or antigen panel with range of reactivities and cross-reactivities o Serial release panel is critical to minimize variation in test results o Panel includes range of reactivity http://209.85.229.132/search?q=cache:Igw5R2Huo4UJ:www.fda.go... |
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5 hrs confidence:
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