Concentration-time graphs and NCA [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2019-02-02 18:30 (1881 d 11:16 ago) – Posting: # 19849
Views: 2,992

Hi ElMaestro & Smitha,

❝ ❝ 2. a. If the actual time-point is used even if the sampling deviation is within the window

❝ ❝       period, is it appropriate? Is there an impact on the PK data e.g AUC?


❝ I think it is common to use the nominal point for both plotting and AUC-calculation when the sample is inside the window (note: not all CROs apply windows). Otherwise use actual time for both.


I suggest to always use the actual time points (individual plots and NCA) and scheduled ones only for summary (by treatment) plots. Only once I saw a report where medians of actual time points were used. IMHO, a little bit over the top.

A note on “time allowance windows”. In most CROs the actual time point has to be recorded in the CRF anyhow. Only if a deviation from the scheduled time is larger than allowed, an explanation has to be given in the CRF (see also this post).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
70 visitors (0 registered, 70 guests [including 5 identified bots]).
Forum time: 05:46 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5