Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Discussion focused on whether PK would be the most sensitive marker of bioequivalence. Furthermore, there was much discussion about the FDA draft guidance for generic fluticasone propionate/salmeterol. The opinion was expressed that the study design is not capable of detecting a non-equivalent product and would require an unfeasibly large sample size.
Source: The AAPS Journal - Category: Drugs & Pharmacology Source Type: research