Bioequivalence and Bioavailability Forum • USFDA requirement for randomization

USFDA requirement for randomization [Regulatives / Guidelines]

posted by Ravi – India, 2012-06-15 15:39 (4750 d 20:23 ago) – Posting: # 8744
Views: 15,591

Hi All,

I have a query regarding USFDA requirement for randomization.

Do we need to submit the SAS code and seed used for randomization schedule generation to FDA as a part of our submission.

What if this schedule is being generated by some other software (Like GRand). What kind of document we need to submit to USFDA?

Regards,
Ravi Shankar Pandey

—
Thanks & Regards
Ravi Pandey

Complete thread:

USFDA requirement for randomizationRavi 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 randomizeBE Helmut 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