Bioequivalence and Bioavailability Forum

Update [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-02 20:11 (4705 d 14:12 ago) – Posting: # 11176
Views: 30,629

Hi John!

❝ ❝ Splendid. Given your results chances that the product does not show a lower BA than the reference are ~0.00005%. Four questions: […]

❝ Hey they pay for for my bills, food, sports car etc etc :-P

I’m fine with most of it. Still I think that if we are not soooo much interested in ethics a – really better paid – job would be investment banker. BTW, not by any chance the first (!) question I was asked in my first workshop in India was: “Would you advise to open up a new CRO to make a lot of money?”
Telling!

❝ Remember I told you about my case a month or so ago? I had to deal with a drug product having ISCV~60% and T/R Ratio ~120% from a pilot study! They wanted me to go for a pivotal and also low-balled my sample size recommendation to ~70% of the computed sample size!

This story? Did you tell the guy in his Armani suit buying a new Lamborghini once its ash tray if full what that means in terms of power?

Thanks for your comprehensive example. ±2SD covers 95.45% of data – so such a cut-off is not completely out of the blue. BTW, Canada considers an outlier if the studentized intra-subject residual is >±3SD (i.e., covering 99.73% of data).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15
- AUCextrap more than 20% ElMaestro 2013-08-01 10:29
  - AUCextrap more than 20% sam 2013-08-01 11:21
    - AUCextrap more than 20% ElMaestro 2013-08-01 11:39
      - AUCextrap more than 20% sam 2013-08-01 12:01
        
        AUCextrap more than 20% Helmut 2013-08-01 12:52
    - forced BE d_labes 2013-08-01 11:59
      - Gambling ♠ ♣ ♥ ♦ Helmut 2013-08-01 13:31
- AUCextrap more than 20% Helmut 2013-08-01 12:32
  - AUCextrap more than 20% sam 2013-08-01 12:55
    - 46% power in study planning? Helmut 2013-08-01 13:18
      - 46% power in study planning? sam 2013-08-01 13:40
        
        46% power in study planning? jag009 2013-08-01 20:04
        
        Re-dosing Helmut 2013-08-02 03:32
        
        Re-dosing jag009 2013-08-02 05:10
        
        Re-dosing Helmut 2013-08-02 14:44
        
        46% power in study planning? sam 2013-08-02 07:00
        
        Carved in stone? Helmut 2013-08-02 03:22
        
        Carved in stone? sam 2013-08-02 07:02
        
        Carved in stone? luvblooms 2013-08-02 08:37
        
        Carved in stone? sam 2013-08-02 09:01
        
        Ethics (again) Helmut 2013-08-02 14:53
        
        Update jag009 2013-08-02 17:25
        
        UpdateHelmut 2013-08-02 18:11
        
        Update jag009 2013-08-02 20:11
        
        Outliers (CAN) Helmut 2013-08-02 20:56
        
        Outliers (CAN) jag009 2013-08-02 22:23
        
        OT: Expert Helmut 2013-08-03 10:11
        
        Update jag009 2013-08-02 22:29
        
        Update ElMaestro 2013-08-02 23:08
        
        Update jag009 2013-08-03 23:00
        
        Update luvblooms 2013-08-05 06:02
        
        Update jag009 2013-08-05 20:14

Update [Study As­sess­ment]

Complete thread:

Update [Study Assessment]