Bioequivalence and Bioavailability Forum

SR formulations [General Statistics]

posted by hirenpharm – Ahmedabad, 2007-01-20 11:05 (7086 d 15:53 ago) – Posting: # 476
Views: 19,120

Dear all,

Please suggest.
If a single dose BE study of a SR product Vs SR product... we find AUC0-last failing but AUC0-T(Tau)(say 0-24 hrs) passing and Cmax and AUC0-inf is also passing (fast and fed) and no need for steady state.

Can be seek TGA approval for the study?

Which objections are anticipated?

regards..

—
Dr. Hiren Mehta

Complete thread:

SR formulationshirenpharm 2007-01-20 10:05 [General Statistics]
- SR formulations - no MD study? Helmut 2007-01-22 19:09
  - SR formulations - no MD study? hirenpharm 2007-01-23 18:13
    - SR formulations - no MD study? Helmut 2007-01-23 18:32
- SR formulations velupharm 2007-01-23 12:38
  - bioanalytics (LLOQ) Helmut 2007-01-23 19:59
    - bioanalytics (LLOQ) velupharm 2007-01-24 05:36
      - bioanalytics (LLOQ) Helmut 2007-01-24 12:40
        
        bioanalytics (LLOQ) joyjac 2007-05-22 02:13
        
        bioanalytics (LLOQ) Ohlbe 2007-05-24 23:02

SR formulations [General Sta­tis­tics]

Complete thread:

SR formulations [General Statistics]