Bioequivalence and Bioavailability Forum

Therapeutic Equivalence vs. Pharmaceutical Quality [Design Issues]

posted by kumarnaidu – Mumbai, India, 2014-03-15 12:36 (4485 d 16:36 ago) – Posting: # 12634
Views: 6,614

Dear All,

We have submitted old tramadol study recently in EU that was conducted as per the old EMA GL. As per the current GL, for establishing BE we have to consider enantiomers of tramadol and its active metabolite. And hence we have recieved the following query from the agency asking the same.
The use of an achiral bioanalytical method for tramadol and its metabolite should be discussed and justified.
Can anyone help me out to defend this ?

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 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 Qualitykumarnaidu 2014-03-15 11:36