Bioequivalence and Bioavailability Forum • Tramadol BE study

Tramadol BE study [Design Issues]

posted by nermina – Bosnia and Herzegovina, 2010-01-15 16:27 (6003 d 15:11 ago) – Posting: # 4608
Views: 9,336

Hello, does anyone have experience with tramadol BE study, precisely is it necessary for granting MA in EU to determinate in BE study the parent drug and metabolite M1, or just the parent drug.

Edit: Category changed. [Helmut]

Complete thread:

Tramadol BE studynermina 2010-01-15 15:27
- Tramadol BE study Helmut 2010-01-15 16:08
  - Tramadol BE study nermina 2010-01-15 16:15
    - Tramadol BE study Helmut 2010-01-15 16:40
      - Tramadol BE study mvgchakravarthi 2010-01-18 15:19
        
        Tramadol BE study Helmut 2010-01-18 15:44
        
        Tramadol BE study raghu 2010-01-20 17:53
        
        MA (EU) vs. ANDA (USA) Helmut 2010-01-20 18:18
      - Tramadol BE study ratna 2010-01-21 06:36
- Tramadol BE study Otto 2010-01-25 13:26
  - Therapeutic Equivalence vs. Pharmaceutical Quality Helmut 2010-02-07 17:01
    - Therapeutic Equivalence vs. Pharmaceutical Quality kumarnaidu 2014-03-15 11:36