Bioequivalence and Bioavailability Forum

Hi ElMaestro and Researcher101,

» As I see it, one can make a case for saying that the way to deal with time point deviations should be API-specific as well as time-specific.

Agree. The later in the profile, the less critical deviations are.

» Some CROs define a window in terms of time (for each time point)…

See this post and followings. I don’t comprehend why too early sampling should be performed. PK calculations (regardless whether by NCA or by modeling) should always be performed based on the actual time points – otherwise the estimates will be biased.
Extremely nasty in modeling. Both OLS and maximum likelihood approaches require that the independent variable is free of any error. It’s a misconception that errors in the independent variable only increase the residual error. If one wants to deal with that, it get’s really, really tricky ( orthogonal regression, where the selection of appropriate weights is black magic).