Bioequivalence and Bioavailability Forum • time points and study design

time points and study design [Design Issues]

posted by MGR – India, 2009-04-01 10:18 (6296 d 21:23 ago) – Posting: # 3429
Views: 3,977

Dear Dr.Muneesh Garg,

The following link may help you regarding the Design etc.,

USFDA Recommendation on Bicalutamide

And we have done the study on Healthy volunteers with an 50 mg dose for USFDA submission with 60 subjects and it passed both Fasting and Fed conditions.

Thank you,

—
Regards,
MGR

Complete thread:

time points and study design drmuneesh 2009-03-31 11:04
- time points and study designMGR 2009-04-01 08:18
  - time points and study design drmuneesh 2009-04-02 11:10
    - selection of time points martin 2009-04-03 08:45
      - selection of time points drmuneesh 2009-04-03 09:42
        
        BE study? martin 2009-04-04 19:40
        
        BE study. Ohlbe 2009-04-04 23:38