Bioequivalence and Bioavailability Forum • Narrow Therapeutic statistics

Narrow Therapeutic statistics [Regulatives / Guidelines]

posted by Compliance – India, 2014-09-10 14:07 (4307 d 02:00 ago) – Posting: # 13473
Views: 3,781

Dear kvgreddy,

Here the window of Tmax wan't work as we argue on that basis also. FDA rejected data and now we are off from that filing . such difference in the Tmax is not acceptable in Narrow Therapeutic Statistics.

Regards,

Compliance

Complete thread:

Narrow Therapeutic statistics Compliance 2012-07-09 07:13
- Narrow Therapeutic statistics hiren379 2012-07-11 06:17
  - Narrow Therapeutic statistics Compliance 2012-07-11 06:29
    - Narrow Therapeutic statistics hiren379 2012-07-11 08:59
  - Tmax required for the FDA? Helmut 2012-07-11 15:59
- Narrow Therapeutic statistics kumarnaidu 2013-04-10 10:27
  - Power? d_labes 2013-04-10 10:38
- Narrow Therapeutic statistics kvgreddy06 2014-09-01 17:13
  - Narrow Therapeutic statisticsCompliance 2014-09-10 12:07