What's the problem? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2017-05-17 14:07 (2507 d 13:10 ago) – Posting: # 17367
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Hi DM,

❝ It would be interesting to study the within study variation for the same compound in the same unit to understand which is the main source of variability. Although I understand the point of El Maestro about assay sensitivity, I don't think that could be pointed as a cause for a study which presented high variability when other studies reported low variability. I understand the approach to highly variable drugs, when the drug is actually highly variable per se and not due to study conduct or assay sensibility.


Then it all comes back to one of Helmut's favourite hobbies, calculation of confidence intervals for variabilities. I think the conclusion generally is that perhaps the drug is highly variable and perhaps it isn't.

Pass or fail!
ElMaestro

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