Bioequivalence and Bioavailability Forum

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

posted by ElMaestro  – Denmark, 2014-09-12 12:14 (4310 d 12:21 ago) – Posting: # 13494
Views: 3,226

Hi Mahesh M,

❝ It means Bioequivalence depends on: Cmax. AUCt and Tmax?

Yes. Generally bioequivalence depends on those three metrics and other stuff, but you are not creating confidence intervals for Tmax.


I agree it might not be too well worded in the guideline. The responsible person should be flogged

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