Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-05-21 11:15 CEST (UTC+2h)

What's the problem? [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-05-17 12:07  - Posting: # 17367
Views: 6,502

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.

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).

Best regards,

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
18,269 posts in 3,882 threads, 1,161 registered users;
19 users online (1 registered, 18 guests).

Science is wonderfully equipped to answer the question “How?”
but it gets terribly confused when you ask the question “Why?”    Erwin Chargaff

BEBAC Ing. Helmut Schütz