Bioequivalence and Bioavailability Forum

Tramadol BE study [Design Issues]

posted by raghu – India, 2010-01-20 18:53 (5999 d 02:07 ago) – Posting: # 4625
Views: 8,010

Dear Nermina,

If an active metabolite is available and it is quantifiable in biological fluid (i.e plasma, urine etc), better to analyse and submit as a supportive evidence.

It may add some additional cost, but it is safer.

Nowadays, Sponsor's initially submit the ANDA submission to the proposed countries (EU), Later on they might submit to the rest of the world. If any query comes after several years, then it would be difficult to answer and product approval may be questionable ???

Regards
Raghavender Chenna

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 studyraghu 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