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RegisterT>MIC for Anti microbial is sufficient to show therapeutic efficacy [Regulatives / Guidelines]
Hi all
I need one help.
My objective is to replace immediate release formulation one antimicrobial with sustained release formulation of the same antimicribial
Can pharmacodynamic end-point (T>MIC) of Sustained Release formulation establish therapeutic effect and hence waive need to do clinical study? or we have to do a clinical study of Sustained release formulation vs immediate release formulation?
I need one help.
My objective is to replace immediate release formulation one antimicrobial with sustained release formulation of the same antimicribial
Can pharmacodynamic end-point (T>MIC) of Sustained Release formulation establish therapeutic effect and hence waive need to do clinical study? or we have to do a clinical study of Sustained release formulation vs immediate release formulation?
Complete thread:
- T>MIC for Anti microbial is sufficient to show therapeutic efficacyheritage 2018-02-17 07:32 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy ElMaestro 2018-02-17 12:11
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy heritage 2018-02-17 14:26
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy ElMaestro 2018-02-17 18:13
- Therapeutic Occupancy Time Helmut 2018-02-17 21:27
- Therapeutic Occupancy Time heritage 2018-02-18 07:19
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy heritage 2018-02-17 14:26
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy ElMaestro 2018-02-17 12:11
Ing. Helmut Schütz