Bioequivalence and Bioavailability Forum • Not cast in stone

Not cast in stone [RSABE / ABEL]

posted by jag009 – NJ, 2014-08-22 18:40 (3917 d 21:47 ago) – Posting: # 13418
Views: 7,549

Hi guys and gals,

But you do realize that you don't have to use the tables exactly as they are right? Example, what if you have to fill in 1) partial AUCs, 2)add in a sprinkled study?

You can modify the tables if you want. I have done it for the above examples. I did the same thing when reporting PK parameters for NDA filing as well...

John

Complete thread:

Model bioequivalence data summary tables-FDA kumarnaidu 2014-08-20 07:04
- FDA: 90% CI for RSABE Helmut 2014-08-20 10:44
  - FDA: 90% CI for RSABE kumarnaidu 2014-08-20 13:30
    - FDA: 90% CI for RSABE Helmut 2014-08-20 14:10
      - Not cast in stonejag009 2014-08-22 16:40
        
        Not cast in stone nobody 2014-08-22 17:17
        
        Not cast in stone jag009 2014-08-23 06:21