Journal of Bioequivalence & Bioavailability

What is the place of knemometry in development of new inhaled Corticosteroids

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

6-7 September 2011 Baltimore, USA

Ole D. Wolthers

Scientific Tracks Abstracts: JBB

Abstract:

D evelopment of new inhaled corticosteroid s with an improved ratio between effi cacy and systemic activity for treatment of asthma is n eeded. Especially, growth suppression is an unwanted adverse eff ect in children. When validated recommendations for standardisation and measurement procedures are used short term assessment of lower leg growth by knemometry is a highly accurate and reproducible method for assessment of systemic activity of inhaled corticosteroids in children. In populations of children short term knemometry is to be capable of defi ning specifi c corticosteroids, application devices and doses that do not suppress long term height growth. If the short term lower leg growth suppression in populations of children is higher than approximately 25% the risk of intermediate term growth suppression becomes signifi cant with a mean height growth rate retardation in the range of approximately 1 cm during the fi rst year of treatment which may be associated with a reduction in fi nal height of the same magnitude. Short term knemometry should be performed as an integral part of the safety assessments of new inhaled corticosteroids an d inhalation devices in children with asthma before intermediate term or long term height growth evaluations are initiated