Bioequivalence and Bioavailability Forum • Replicate Study designs

Replicate Study designs [Outliers]

posted by Mahesh M – India, 2014-01-08 14:18 (4200 d 03:49 ago) – Posting: # 12145
Views: 15,361

Dear balakotu

I agree with Dr. Dan, if those two subjects data pass outliers test then only you exclude the subjects and in that condition you have to submit excluded and included PK analysis data to regulatory agency.
Regards
Mahesh M

Complete thread:

Replicate Study designs balakotu 2014-01-08 08:14 [Outliers]
- Replicate Study designs Dr_Dan 2014-01-08 09:54
  - Replicate Study designsMahesh M 2014-01-08 13:18
    - Replicate Study designs Dr_Dan 2014-01-08 15:24
      - Replicate Study designs jag009 2014-01-08 15:33
      - Re-testing Helmut 2014-01-08 16:16
- Replicate Study designs Ohlbe 2014-01-08 14:24