Bioequivalence and Bioavailability Forum • Reference Listed Drug

Reference Listed Drug [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2017-04-19 11:43 (2558 d 02:21 ago) – Posting: # 17252
Views: 5,191

Hi arpit.patel,

❝ Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.?

I have good experience with it (EU+US+Brazil). There are sometimes good reasons to do it, and sometimes no way around it. I am not aware of specific guidance.

—
Pass or fail!
ElMaestro

Complete thread:

Reference Listed Drug kiranActimus 2011-05-11 10:36 [Regulatives / Guidelines]
- Reference Listed Drug Helmut 2011-05-11 11:35
  - Reference Listed Drug kiranActimus 2011-05-11 11:50
    - Reference Listed Drug Helmut 2011-05-11 11:59
      - Reference Listed Drug kiranActimus 2011-05-11 12:12
        
        Reference Listed Drug luvblooms 2011-06-01 09:30
      - Reference Listed Drug arpit.patel 2017-04-19 06:04
        
        Reference Listed DrugElMaestro 2017-04-19 09:43