Bioequivalence and Bioavailability Forum • Parallel study as pilot for long half life drug

Parallel study as pilot for long half life drug [Design Issues]

posted by Dr_Dan – Germany, 2012-05-07 18:00 (5148 d 02:54 ago) – Posting: # 8525
Views: 5,770

Dear John
running a pilot parallel study does not necessarily mean that you have to conduct your pivotal studies also as parallel studies. But considering the long half life of the drug it is IMHO not reasonable to conduct a cross-over study. The CV% you get from the pilot is the total CV%, right. You use this to calculate your sample size for the pivotal study but it does not predetermine the design of the pivotal study.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Parallel study as pilot for long half life drug jag009 2012-05-07 15:13 [Design Issues]
- Parallel study as pilot for long half life drugDr_Dan 2012-05-07 16:00
  - Parallel study as pilot for long half life drug d_labes 2012-05-07 16:24
  - Parallel study as pilot for long half life drug jag009 2012-05-07 18:15
    - AUC72 Helmut 2012-05-07 19:31
      - AUC72 jag009 2012-05-07 20:15
        
        AUC72 Dr_Dan 2012-05-08 12:17
        
        AUC72 jag009 2012-05-10 15:15
        
        AUC72: NDAs Helmut 2012-05-10 15:56
        
        AUC72: NDAs jag009 2012-05-14 15:22