Bioequivalence and Bioavailability Forum • Tramadol BE study

Tramadol BE study [Design Issues]

posted by mvgchakravarthi – India, 2010-01-18 16:19 (5998 d 12:24 ago) – Posting: # 4613
Views: 7,956

Dear Nermina

As per FDA BE guidance document, need to estimate parent "Tramadol" only but not metabolite.

Regards
M.V.G.Chakravarthi

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Complete thread:

Tramadol BE study nermina 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 studymvgchakravarthi 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