Bioequivalence and Bioavailability Forum • metformin steady state study

metformin steady state study [Regulatives / Guidelines]

posted by Ohlbe – France, 2011-06-02 10:56 (5085 d 15:38 ago) – Posting: # 7055
Views: 10,295

Dear Dr Gunasakaran,

❝ As per FDA's Bioequivalence recommendations for Metformin Extended release tablets, they recommended to conduct Single dose, two way cross over Fasting and Fed studies only, not Steady State study.

True for FDA. But a steady state study is needed for EU submission.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

metformin steady state study jagankm 2011-06-01 11:19 [Regulatives / Guidelines]
- metformin steady state study Ohlbe 2011-06-01 11:31
- metformin steady state study drgunasakaran1 2011-06-02 04:24
  - metformin steady state studyOhlbe 2011-06-02 08:56
  - metformin steady state study jagankm 2011-06-02 10:35
    - Steady state (no accumulation) Helmut 2011-06-03 14:58
      - Steady state (no accumulation) Ohlbe 2011-06-06 10:46
        
        Steady state (no accumulation) Helmut 2011-06-06 13:05
        
        Steady state (no accumulation) Ohlbe 2011-06-06 13:54
        
        Science ↔ Guidelines Helmut 2011-06-06 14:06
        
        Science ↔ Guidelines ElMaestro 2011-06-06 22:35
        
        Science ↔ Guidelines Helmut 2011-06-06 23:25
    - metformin steady state study kvgreddy06 2014-07-23 18:32