Bioequivalence and Bioavailability Forum • Not blinding sampling times

Not blinding sampling times [Bioanalytics]

posted by Obinoscopy – USA, 2018-08-20 00:20 (1866 d 19:07 ago) – Posting: # 19177
Views: 3,240

Hi Helmut,

❝ Even if substantial carry-over is not apparent in method validation (which would call for injecting mobile phase between samples), it exists. The EMA’s GL tells us [...]

Going by that guideline, will it be safe to say that the converse it also true. That is:

If it appears there is no carry-over, study samples should be randomised

Well, just as you said, carryover is always very likely. Thus complete randomisation will not be the reasonable path to follow.

Thanks guys, at least I am glad I let my thoughts out and not get drowned in them.

—
Scopy

Complete thread:

Blinding in Bioanalysis Obinoscopy 2018-08-19 16:22 [Bioanalytics]
- Blinding in Bioanalysis ElMaestro 2018-08-19 18:46
  - Not blinding sampling times Helmut 2018-08-19 19:06
    - Not blinding sampling timesObinoscopy 2018-08-19 22:20
  - Blinding in Bioanalysis Obinoscopy 2018-08-19 21:37