Bioequivalence and Bioavailability Forum • subject inclusion criteria in PK and stat and BE conclusion

subject inclusion criteria in PK and stat and BE conclusion [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2017-09-05 10:26 (2424 d 11:22 ago) – Posting: # 17777
Views: 6,834

Hi Ramesh,

Statistics:
EU: Include those who provide both a Test and Reference period.
US: Include those who provide data.

Descriptive PK: Done on all data as much as possible.

I have a feeling you may have asked about something else, though?

—
Pass or fail!
ElMaestro

Complete thread:

subject inclusion criteria in PK and stat and BE conclusion Ramesh Ramalingam 2017-09-05 07:35 [Regulatives / Guidelines]
- subject inclusion criteria in PK and stat and BE conclusionElMaestro 2017-09-05 08:26
  - subject inclusion criteria in PK and stat and BE conclusion Ramesh Ramalingam 2017-09-05 09:17
    - subject inclusion criteria in PK and stat and BE conclusion ElMaestro 2017-09-05 09:20
      - subject inclusion criteria in PK and stat and BE conclusion Ramesh Ramalingam 2017-09-05 09:22
        
        subject inclusion criteria in PK and stat and BE conclusion ElMaestro 2017-09-05 10:16
    - At least twice R or twice T for sWR and sWT yicaoting 2017-09-05 15:23