Bioequivalence and Bioavailability Forum • exact matching of CCs (validation’s and study’s)

exact matching of CCs (validation’s and study’s) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2017-05-31 14:41 (2958 d 08:04 ago) – Posting: # 17430
Views: 7,691

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. :-D

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!
Helmut Schütz

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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 13:46
    - Sapere aude! Helmut 2017-05-31 14:46