Bioequivalence and Bioavailability Forum

I appreciate the comments and thoughts on my blog post. Perhaps my comments were taken out of context. The context of my comments was whether or not we need to define a "window" during which we must draw a blood sample. And if the sample is outside of that window we declare it a protocol deviation.

As this group stated time point selection is very important to accurately capture the characteristics of a pharmacokinetic profile. We often use optimization algorithms to choose the best time points.

However, once the nominal time points are chosen, does it really matter if a sample is drawn 5-15 minutes early or late? Unless that deviation overlaps a subsequent nominal sampling time, I still posit that it does not matter. As an example, if your sampling times are 0.5, 1, and 1.5 hours. The sample at 1 hour can be taken at 0.75, 1, or 1.25 hrs and still give reasonable results.

Interested in your thoughts ...

Nathan Teuscher

---

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]