Bioequivalence and Bioavailability Forum • metformin steady state study

metformin steady state study [Regulatives / Guidelines]

posted by jagankm – 2011-06-02 12:35 (5085 d 14:01 ago) – Posting: # 7056
Views: 10,304

❝ As per FDA's Bioequivalence recommendations…

Dear Dr,

Thank you for your response.

we are planning this study for EU submission.

on scientific basis when there is no accumulation of drug on repeated administration what is the use of conducting steady state study. SPC of innovator itself noticing there is no accumulation of metformin after repeated administration. in this regard is it necessary to for steady state study as per guidelines. is there any way to skip to conduct steady state study for metformin for EU submission.

please suggest…

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]

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 study Ohlbe 2011-06-02 08:56
  - metformin steady state studyjagankm 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