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Registerpressurised metered dose inhalers (pMDIs) [Regulatives / Guidelines]
Dear All,
My concern is about Pharmacokinetic parameters for pressurised metered dose inhalers (pMDIs) EMA submission Study.
As per the guideline http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf
London, 22 January 2009 Doc. Ref. CPMP/EWP/4151/00 Rev. 1 Section 6.1.1 (page no10.)
“In accordance with the standard accepted methods of assessment of bioequivalence the maximum concentration (Cmax), the area under the curve (AUC) and the time to Cmax (Tmax) should be compared.”
It means Bioequivalence depends on: Cmax. AUCt and Tmax?
Regards
My concern is about Pharmacokinetic parameters for pressurised metered dose inhalers (pMDIs) EMA submission Study.
As per the guideline http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf
London, 22 January 2009 Doc. Ref. CPMP/EWP/4151/00 Rev. 1 Section 6.1.1 (page no10.)
“In accordance with the standard accepted methods of assessment of bioequivalence the maximum concentration (Cmax), the area under the curve (AUC) and the time to Cmax (Tmax) should be compared.”
It means Bioequivalence depends on: Cmax. AUCt and Tmax?
Regards
Complete thread:
- pressurised metered dose inhalers (pMDIs)Mahesh M 2014-09-12 08:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pressurised metered dose inhalers (pMDIs) ElMaestro 2014-09-12 10:14
- pressurised metered dose inhalers (pMDIs) nobody 2014-09-12 10:26
- pressurised metered dose inhalers (pMDIs) Mahesh M 2014-09-16 07:57
- pressurised metered dose inhalers (pMDIs) ElMaestro 2014-09-16 08:45
- pMDIs: Tmax Helmut 2014-09-16 09:21
- pressurised metered dose inhalers (pMDIs) ElMaestro 2014-09-12 10:14
Ing. Helmut Schütz