Table VI.

Comparison of Bioequivalence Recommendations on Pharmacodynamics Studies for Systemic Safety of European Medicines Agency and Health Canada for Locally Acting Orally Inhaled Drug Products

Similarities PD marker	To assess the effect on the hypothalamic–pituitary adrenocortical (HPA) axis in adults
Dose	HC: single- or multiple-dose study to compare T and R EMA: no information provided
Study details	Similarities: serum cortisol area under the 24-h curve Differences: HC: • Serum cortisol is measured every two hours for 24 h. EMA: • Adults: C max during 24 h measurement. • Steady state has to be reached. • There are special considerations for children
Acceptance criteria	HC: log or non-log data; 90% CIs of T/R SCO-24 AUC should be within 80–125% EMA: no information provided

HC Health Canada, EMA European Medicines Association