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RegisterClinical Equivalence Studies [Off Topic]
Dear Jaime,
Since this is an off topic, I would be bold to add few lines here. Clinical equivalence are those studies in my opinion where there is a need to see pharmacodynamic end points rather than concentrations in blood. Examples are meter-dose inhalers (MDIs). There are canadian and other guidelines how to conduct studies for approval of generic MDIs. Some studies we have conducted on MDIs involved the measurement of FEV1 activity in mild to moderate asthmatic patients. There may be few more expamles on this list.
Dr. Shiv
Edit: Full quote removed. [HS]
Since this is an off topic, I would be bold to add few lines here. Clinical equivalence are those studies in my opinion where there is a need to see pharmacodynamic end points rather than concentrations in blood. Examples are meter-dose inhalers (MDIs). There are canadian and other guidelines how to conduct studies for approval of generic MDIs. Some studies we have conducted on MDIs involved the measurement of FEV1 activity in mild to moderate asthmatic patients. There may be few more expamles on this list.
Dr. Shiv
Edit: Full quote removed. [HS]
Complete thread:
- Clinical Equivalence Studies Jaime_R 2007-02-23 11:20
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Clinical Equivalence Studies Helmut 2007-02-23 13:42
- Clinical Equivalence Studiesdrshiv 2007-02-25 15:23
- Clinical Equivalence Studies Jaime_R 2007-02-26 11:45
Ing. Helmut Schütz