Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report

In April 2010 a workshop on the “Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products” was sponsored by the Product Quality Research Institute (PQRI) in coordination with Respiratory Drug Delivery (RDD) 2010. The objective of the workshop was to evaluate the current state of knowledge and identify gaps in information relating to the potential use of pharmacokinetics (PK) as the key indicator of in vivo...