Bioequivalence and Bioavailability Forum • FDA: antique of ’93

FDA: antique of ’93 [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-12-11 17:29 (4581 d 00:31 ago) – Posting: # 12039
Views: 14,847

Hi John,

❝ ❝ BTW: Your partial replicate nightmare (#10563). Did you receive an answer from Mr Schuirmann?

❝

❝ Nope. I emailed him two questions and no feedback so far (2nd one was about stats for a partial rep study having 2 groups).

So far? Unbelievable. Ask your legal department to get refund from the FDA for the study you performed exactly following the guidance only to get from SAS:

WARNING: Did not converge. WARNING: Output 'Estimates' was not created.

—
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:

FDA: Size of bio-batch Helmut 2013-12-10 14:05
- FDA: Size of bio-batch jag009 2013-12-10 20:03
  - FDA: antique of ’93 Helmut 2013-12-10 23:32
    - FDA: antique of ’93 jag009 2013-12-11 15:23
      - FDA: antique of ’93 Helmut 2013-12-11 15:26
        
        FDA: antique of ’93 jag009 2013-12-11 16:21
        
        FDA: antique of ’93Helmut 2013-12-11 16:29
        
        FDA: antique of ’93 jag009 2013-12-11 23:16
        
        Patience Helmut 2013-12-12 14:34
    - FDA: antique of ’93 Beholder 2018-06-21 09:21
      - Nice numbers Helmut 2018-06-21 15:05
        
        Nice numbers Beholder 2018-06-22 10:33
        
        Type II variation Helmut 2018-06-22 15:12
      - Birdsong's third law of BE ElMaestro 2018-06-22 10:10
        
        Experience Beholder 2018-06-22 11:04
        
        Why, oh why? Helmut 2018-06-22 15:17
        
        Sorry for the delay Beholder 2018-10-18 09:40