Bioequivalence and Bioavailability Forum

Dear forum members!

This is regarding the evaluation of Tmax for orally inhahled product, as per EMA guideline "Requirements for Clinical Documentation for Orally Inhaled Products (OIP) including the Requirements for Demonstration of Therapeutic Equivalence between two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD)" section 6.1.1 Pharmacokinetic studies, para 3

' 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. Equivalent pulmonary deposition and equivalent systemic safety of two inhaled products may be concluded if the 90 % confidence interval for each parameter lies within the acceptance range of 0.8 to 1.25.'

As mentioed above we have to consider Tmax also for the conclusion of Bioequivalence with criteria of 90% CI (80-125%)as it has been mentioned for each parameter? Now for Tmax should we use non parametric test for 90% CI or parametric test as normally we use non-parametric test for the evaluation of Tmax?

Regards,

Ratnakar