Bioequivalence and Bioavailability Forum

R-package randomizeBE [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-07-06 14:51 (5092 d 12:04 ago) – Posting: # 8901
Views: 14,703

Dear Detlew!

❝ R-package randomizeBE

THX, wonderful!

❝ BTW: Helmut how did you act on the deficiency letter 20+ years ago?

I implemented the WW-test and generated a new randomization if p<0.05.

❝ Could you convince them that dicing 6 times in series 6 pips (or six times 1 pips) although has low probability is possible?

No way. At that time CROs / clinical sites were randomly [sic] chosen by the Austrian Ministry of Health for GCP (facility) inspections. My rep("RT", "TR", 6) in one study was a ‘minor finding’ – in the next inspection they were very happy about my changed code. I wonder how the MoH’s random generator worked.

—
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:

• USFDA requirement for randomization Ravi 2012-06-15 13:39 [Regulatives / Guidelines] 
  • randomization: validation Helmut 2012-06-15 17:39
    • randomization: runs test? validation? d_labes 2012-06-16 13:10
      • randomization: runs test? validation? Helmut 2012-06-16 14:00
        • probability nearly zero? d_labes 2012-06-16 16:11
          • probability nearly zero! Helmut 2012-06-16 17:08
            • R-package randomizeBE d_labes 2012-07-06 09:54
              • R-package randomizeBEHelmut 2012-07-06 12:51
    • randomization: validation ElMaestro 2012-06-16 13:31
      • randomization: runs test Helmut 2012-06-16 14:42
        • randomization: runs test ElMaestro 2012-06-16 14:48
          • randomization: runs test Helmut 2012-06-16 15:10
        • very cool coding style ElMaestro 2012-06-16 19:12
          • Better a good steal than a bad reinvention Helmut 2012-06-17 13:22
            • Better a good steal than a bad reinvention ElMaestro 2012-06-17 19:58
              • Sorry! Helmut 2012-06-18 13:26
                • Sorry! ElMaestro 2012-06-18 15:19
          • Dancing with the dice d_labes 2012-06-18 15:38
            • Silly's randomization 2x2 xover d_labes 2012-06-18 16:30
              • Silly's randomization 2x2 xover Helmut 2012-06-18 17:14
            • Clumsy code Helmut 2012-06-18 17:42
              • Clumsy code ElMaestro 2012-06-18 18:01
                • Speed kills Helmut 2012-06-18 18:56
                  • Speed kills jag009 2012-09-17 21:46