Bioequivalence and Bioavailability Forum • pressurised metered dose inhalers (pMDIs)

pressurised metered dose inhalers (pMDIs) [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2014-09-16 10:45 (4305 d 02:29 ago) – Posting: # 13515
Views: 3,043

Hi Mahesh M,

❝ Then how we compare the Tmax as BE criteria?

Descriptive statistics + commentary + perhaps Wilcoxon's signed rank.
For beta2 agonists Tmax is sometimes-often on the first or second sample and thus not well characterised by the sampling. It is difficult to plan your way out of it.

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

"Feature, not bug."

I wish.

—
Pass or fail!
ElMaestro

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: Tmax Helmut 2014-09-16 09:21