Freigabepanel

English translation: release panel

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Freigabepanel
English translation:release panel
Entered by: Marga Shaw

09:38 Jan 25, 2010
German to English translations [PRO]
Science - Other
German term or phrase: Freigabepanel
Aus einer Leistungsbewertungsstudie für einen Testkit. Es geht um die Probenherkunft, bzw. Probenspezifität.
Die Proben der Blutspender stammen aus dem ELISA-Freigabepanel.
CArcher
Germany
Local time: 14:31
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...
Selected response from:

Marga Shaw
United Kingdom
Local time: 13:31
Grading comment
thanks
4 KudoZ points were awarded for this answer



Summary of answers provided
2 +2release panel
Marga Shaw
3approval panel
jccantrell


  

Answers


17 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +2
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...


Marga Shaw
United Kingdom
Local time: 13:31
Works in field
Native speaker of: German
PRO pts in category: 20
Grading comment
thanks

Peer comments on this answer (and responses from the answerer)
agree  Rolf Keiser: seems right to me.
15 mins
  -> Thank you Goldcoaster!

agree  gangels (X)
7 hrs
  -> Thank you Gangels!
Login to enter a peer comment (or grade)

5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
approval panel


Explanation:
What I thought of. Also a possibility.


    Reference: http://www.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb...
    Reference: http://www.doctors4justice.net/2009/10/rcpsych-to-consider-p...
jccantrell
United States
Local time: 06:31
Native speaker of: Native in EnglishEnglish
PRO pts in category: 16
Login to enter a peer comment (or grade)



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