exact matching of CCs (validation’s and study’s) [Regulatives / Guidelines]
Hi Sushil,
welcome to the BEBA-Forum! Before asking for help: What are your own thoughts?
Bioanalysts should be blinded for treatment but not blind. Science first, regulations second. SCNR.
IMHO, exceeding the upper limit of the CCs in the study compared to the validation by 0.12% (X), 0.04% (Y), or even 1.22% (Z) is simply irrelevant. However, I’m not aware of any GL giving a specific limit.
See also a similar thread (whether it is possible to match CCs and QCs).
welcome to the BEBA-Forum! Before asking for help: What are your own thoughts?
Bioanalysts should be blinded for treatment but not blind. Science first, regulations second. SCNR.

IMHO, exceeding the upper limit of the CCs in the study compared to the validation by 0.12% (X), 0.04% (Y), or even 1.22% (Z) is simply irrelevant. However, I’m not aware of any GL giving a specific limit.
See also a similar thread (whether it is possible to match CCs and QCs).
—
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)
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Science Quotes
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
Complete thread:
- change in CC range sushil.pimpare 2017-05-31 09:31 [Regulatives / Guidelines]
- exact matching of CCs (validation’s and study’s)Helmut 2017-05-31 12:41
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s) ElMaestro 2017-05-31 14:11
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 15:38
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 13:46
- Sapere aude! Helmut 2017-05-31 14:46
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s)Helmut 2017-05-31 12:41