Bioequivalence and Bioavailability Forum

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

posted by jag009  – NJ, 2012-05-07 17:13 (5148 d 12:07 ago) – Posting: # 8524
Views: 6,600

Hi everyone,

I am working on a drug with a half life of 100-120 hrs and so far I haven't been able to get any information about its intrasubject CV. Due to timing issues, I am considering running a pilot parallel study to compare a prototype generic against the innovator.

Question. If I proceed with this, does that mean I will have to conduct my pivotal studies as parallel studies since the CV I get from the pilot is the total CV?

Thanks

John

Complete thread:

• Parallel study as pilot for long half life drugjag009 2012-05-07 15:13 [Design Issues] 
  • Parallel study as pilot for long half life drug Dr_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