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 bioequivalence (BE) of locally acting orally inhaled products (OIPs). In addition, the strengths and limitations of the PK approach to detect differences in product performance compared with in vitro and pharmacodynamic (PD)/clinical/therapeutic equivalence (TE) studies were discussed. The workshop discussed the relationship between PK and lung deposition, in vitro assessment, and PD studies and examined potential PK study designs that could serve as pivotal BE studies. It has been recognized that the sensitivity to detect differences in product performance gener...