calibration curve range [Bioanalytics]

posted by Ohlbe – France, 2016-03-03 17:46 (2947 d 12:35 ago) – Posting: # 16046
Views: 7,048

Dear Ritesh Korat,

❝ Firstly monitor around 20% of first subject of the study.


Why wait till 20 %, if it is already visible after 2-3 runs that the concentrations are lower than expected ?

❝ if Cmax of both period in 14 (67% of 20) subjects out of that 20 subjects cross two QC level than no need of additional QC


Why 67 % ? Where did you take that figure from ?

IMHO what's important is not just how many subjects have a Cmax below the MQC sample - but also how much below it is.

❝ and if its not than add one more QC between LQC and MQC.


Or adjust the concentration of the existing MQC. The guidelines also gives this option.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
96 visitors (0 registered, 96 guests [including 6 identified bots]).
Forum time: 06:22 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