Bioequivalence and Bioavailability Forum • Loosing patience

Loosing patience [Software]

posted by Helmut – Vienna, Austria, 2014-07-01 20:23 (3947 d 12:55 ago) – Posting: # 13197
Views: 26,962

Hi Zan,

the company asked the FDA in October 1998 for a comment and – if I interpret the table correctly – planned the study for November. I’m too lazy to browse through the document, but I guess that sooner or later they gave up waiting and performed the study anyhow. Almost one year later the company received FDA’s answer. Too bad that they didn’t have a crystal ball (which would have told them to go with option #9).
As one of my friends use to say:

Don’t worry, it’s too late.

But we know better now.

—
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:

Phoenix WNL to handle 2x2 crossover study with multip group zan 2014-06-27 23:29
- Phoenix WNL to handle 2x2 crossover study with multip group ElMaestro 2014-06-28 23:23
- Group effect commonly not relevant Helmut 2014-06-30 16:55
  - Group effect in 2x2 BE study zan 2014-06-30 19:18
    - Group effect in 2x2 BE study ElMaestro 2014-06-30 20:36
    - To pool or not to pool Helmut 2014-06-30 20:51
      - To pool or not to pool zan 2014-06-30 21:02
        
        To pool or not to pool Helmut 2014-06-30 21:38
        
        To pool or not to pool zan 2014-06-30 21:46
        
        To pool or not to pool Helmut 2014-06-30 22:22
        
        To pool or not to pool zan 2014-07-01 01:15
        
        Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
        
        Partial vs. sequential tests in WNL zan 2014-07-01 18:03
        
        Loosing patienceHelmut 2014-07-01 18:23
        
        To pool or not to pool ElMaestro 2014-06-30 22:11
        
        To pool or not to pool zan 2014-07-01 01:18
        To pool or not to pool zan 2014-07-02 19:56
        
        To pool or not to pool ElMaestro 2014-07-03 00:17
        
        To pool or not to pool zan 2014-07-03 00:36
        
        sequence- / period effect #666 Helmut 2014-07-03 10:05
  - Group effect commonly not relevant AngusMcLean 2014-07-06 16:19
    - Group effect commonly not relevant Helmut 2014-07-06 20:32
      - Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
        
        Group effect commonly not relevant Helmut 2014-07-06 23:57
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
        
        PHX: Parameter mapping Helmut 2014-07-07 15:45
        
        PHX: Parameter mapping Shuanghe 2014-07-07 17:35
        
        Great hint! Helmut 2014-07-07 17:54
        PHX: Parameter mapping AngusMcLean 2014-07-07 20:49
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 18:46