Bioequivalence and Bioavailability Forum • metformin steady state study

metformin steady state study [Regulatives / Guidelines]

posted by drgunasakaran1 – 2011-06-02 06:24 (5504 d 05:04 ago) – Posting: # 7054
Views: 11,545
(edited on 2011-06-02 11:21)

Dear Mr.Jagan,

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.

Reference

Edit: GL linked. [Jaime]

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

metformin steady state study jagankm 2011-06-01 11:19
- metformin steady state study Ohlbe 2011-06-01 11:31
- metformin steady state studydrgunasakaran1 2011-06-02 04:24
  - metformin steady state study Ohlbe 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