Bioequivalence and Bioavailability Forum

First point Cmax [Study Assessment]

posted by rana – India, 2012-08-18 08:48 (4650 d 11:19 ago) – Posting: # 9078
Views: 7,981

❝ First point Cmax always raises the question about the actual measurement of true Cmax or not, due to inadequate early sampling time points. First point Cmax will be acceptable by US FDA, if you had one early time point between 05 and 15 minutes and additional 02 to 05 sampling time points within 01 hour of dosing.

Dear Dr gunasakaran,
one of our study we got first point cmax for some subjects our sampling points were 0.00, 0.50, 1.00 hr... and as per literature tmax is 1 hr to 4 hr. Whether US regulatory is accepting this fact? and does it show any impact in Pharmacokinetic & statistical analysis?
Regards,
rana.

Complete thread:

First point Cmax auditor 2012-02-10 06:50
- First point Cmax drgunasakaran1 2012-02-10 07:00
  - First point Cmaxrana 2012-08-18 06:48
    - First point Cmax drgunasakaran1 2012-08-21 07:01
- First point Cmax lukamar 2012-09-10 13:54

First point Cmax [Study As­sess­ment]

Complete thread:

First point Cmax [Study Assessment]