Bioequivalence and Bioavailability Forum • pMDIs: Tmax

pMDIs: Tmax [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-09-16 11:21 (4297 d 12:30 ago) – Posting: # 13517
Views: 2,965

Hi Mahesh,

❝ Why Tmax is selected as Primary criteria for estimation BE for pressurised metered dose inhalers (pMDIs)?

If you are suffering from asthma and/or COPD, wouldn’t you say that t_max matters?

BTW, when the NfG was developed, nonparametric statistics were not as taboo in the EU as they are now. CPMP/EWP/QWP/1401/98 states:

Statistical evaluation of t_max only makes sense if there is a clinically relevant claim for rapid release or action […]. The non-parametric 90% confidence interval for this measure of relative bioavailability should lie within a clinically determined range.

Don’t ask me for acceptance range(s).

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Complete thread:

pressurised metered dose inhalers (pMDIs) Mahesh M 2014-09-12 08:46
- 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: TmaxHelmut 2014-09-16 09:21