Bioequivalence and Bioavailability Forum • 2nd opinion

2nd opinion [RSABE / ABEL]

posted by jag009 – NJ, 2013-04-05 17:24 (4423 d 06:11 ago) – Posting: # 10353
Views: 9,479

Hi Helmut!

❝ Bad luck. Reformulate since in the unscaled analysis the lower 90% CL of 134.02% > 125.00% – demonstrating bioinequivalence.

Yes the study was a dud :-P

I was trying to use the dataset and results to validate my SAS code. I already validated my code with another study but was trying to validate with this one again just to kill time. I didn't know I would end up with this turd from the CRO.

So my computation is correct then ;-)

I still don't understand why they didn't use the FDA sequence as is (1=TRR, 2=RTR, 3=RRT) instead of using their own (1=BAB, 2=ABB, 3=BBA). Oh well.

Thank v much for your help.

John

P.S. Did you have a good time with my professor laszlo Endrenyi during your last seminar/conference? Great guy.

Complete thread:

SAS Procedure on Partial Replicate (TRR) Study Data jag009 2013-04-02 21:11 [RSABE / ABEL]
- Confusing… Helmut 2013-04-03 13:42
  - Confusing… jag009 2013-04-03 16:06
    - Confusing… Helmut 2013-04-03 21:49
      - Confusing… jag009 2013-04-03 23:01
        
        Confusing… Helmut 2013-04-03 23:22
        
        Confusing… jag009 2013-04-04 15:59
        Confusing… jag009 2013-04-04 17:21
        
        2nd opinion Helmut 2013-04-05 01:01
        
        2nd opinionjag009 2013-04-05 15:24
        
        3rd, 4th opinion d_labes 2013-04-05 11:04
        
        3rd, 4th opinion jag009 2013-04-05 15:41
        
        Beer swaped d_labes 2013-04-05 16:09
        
        Beer swaped jag009 2013-04-05 17:18