Inhaled Corticosteroid | bioequivalence.eu

Inhaled Corticosteroid

bioequivalence between two inhaled corticosteroids Safety investigations must be carried out following inhalation of the maximum recommended daily dose of the ICS regularly over time. Systemic safety should be demonstrated through pharmacokinetic bioequivalence and measurement of pharmacodynamic parameters.

The current view in respect of the measurement of systemic effects of ICSs is to assess the effect on the hypothalamic pituitary adrenocortical (HPA) axis and/or on lower leg bone growth rate (Knemometry).

The hypothalamic pituitary adrenocortical axis is evaluated by the diurnal cortisol production which may be measured in blood or urine. The ACTH short stimulation test is not recommended and should not be used for the assessment of the systemic effects of ICSs in children.

Knemometry is validated, accurate and reproducible and has been used previously in the early assessment of systemic safety of ICSs in children.

bioequivalence.eu
Professor Hans Bisgaard • Copenhagen • Denmark • Bisgaard@copsac.com