Log in
RegisterFirst point Cmax [Study Assessment]
Dear Mr.Auditor,
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.
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.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- First point Cmax auditor 2012-02-10 06:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- First point Cmaxdrgunasakaran1 2012-02-10 07:00
- First point Cmax rana 2012-08-18 06:48
- First point Cmax drgunasakaran1 2012-08-21 07:01
- First point Cmax rana 2012-08-18 06:48
- First point Cmax lukamar 2012-09-10 13:54
- First point Cmaxdrgunasakaran1 2012-02-10 07:00
Ing. Helmut Schütz