Bioequivalence and Bioavailability Forum • Accepted time deviations in Ambulatory PK intervals

Accepted time deviations in Ambulatory PK intervals [Regulatives / Guidelines]

posted by Researcher101 – Egypt, 2020-11-22 12:52 (1244 d 05:51 ago) – Posting: # 22075
Views: 1,638

❝ Some CROs define a window in terms of time (for each time point); if the sample is taken with the window then the nominal time is used for PK (for AUC calculation), otherwise the actual time. Some CROs will always use the actual time. Both approaches seem to work well across jurisdictions. The option that does not work is to use nominal time regardless of sampling time.

So if I have a time window 12 h and I have a participant come after 18 h so Will I take this sample or not? Please note that the delay will be considered in the statistics calculations

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 #5! Please follow the Forum’s Policy. [Helmut]

Complete thread:

Accepted time deviations in Ambulatory PK intervals Researcher101 2020-11-20 17:59
- Accepted time deviations in Ambulatory PK intervals ElMaestro 2020-11-21 10:08
  - Accepted time deviations in Ambulatory PK intervalsResearcher101 2020-11-22 11:52
  - Accepted time deviations in Ambulatory PK intervals Helmut 2020-11-23 11:49