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).