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RegisterSteady state (no accumulation) [Regulatives / Guidelines]
Dear Helmut and Jagankm,
Maybe, but it will take another couple of years before the draft is published for 6-month consultation, comments are received, a final version gets adopted and it comes into force. Until then the current guidance remains applicable... I would say the attitude depends on how critical this project is for your company, how much time you are ready to spend in discussions with various Agencies, in which EU Member State you plan to submit your dossier and when. If you want to be on the safe side, running the steady state study is expensive and may not sound scientifically necessary, but it may in the end be faster and with a more certain result.
Regards
Ohlbe
❝ According to current thinking of EMA1,2 (internal draft #8 of the MR-GL as of May 2011) steady state studies will not have to be performed any more – if no accumulation is demonstrated in the single dose study (AUCt/AUC∞ > 80%).
Maybe, but it will take another couple of years before the draft is published for 6-month consultation, comments are received, a final version gets adopted and it comes into force. Until then the current guidance remains applicable... I would say the attitude depends on how critical this project is for your company, how much time you are ready to spend in discussions with various Agencies, in which EU Member State you plan to submit your dossier and when. If you want to be on the safe side, running the steady state study is expensive and may not sound scientifically necessary, but it may in the end be faster and with a more certain result.
Regards
Ohlbe
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- metformin steady state study jagankm 2011-06-01 11:19 [Regulatives / Guidelines]
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- 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 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
- Science ↔ Guidelines ElMaestro 2011-06-06 22:35
- Science ↔ Guidelines Helmut 2011-06-06 14:06
- Steady state (no accumulation) Ohlbe 2011-06-06 13:54
- Steady state (no accumulation) Helmut 2011-06-06 13:05
- Steady state (no accumulation)Ohlbe 2011-06-06 10:46
- metformin steady state study kvgreddy06 2014-07-23 18:32
- Steady state (no accumulation) Helmut 2011-06-03 14:58
Ing. Helmut Schütz