Bioequivalence for Orally Inhaled and Nasal Drug Products

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 13)


Bioequivalence (BE) of conventional oral dosage forms intended for systemic action is typically established by comparing drug concentration in plasma or urine following administration of test and reference products to healthy human subjects at the same dose and under similar conditions. However, this approach is not directly applicable to demonstrate BE of orally inhaled and nasal drug products intended for local action, primarily due to lack of relevance of drug concentration in blood/urine to the drug available at the local site(s) of action. Therefore, establishing BE for these drug products is based on an aggregate weight-of-evidence approach, which utilizes in vitro studies, pharmacokinetic studies, and pharmacodynamic/clinical endpoint BE studies to establish equivalence in in vitro performance, systemic exposure, and local delivery, respectively. This chapter discusses the important aspects for establishing BE for locally acting orally inhaled and nasal spray drug products.


Fluticasone Propionate Nasal Spray Reference Product Dose Inhaler Local Drug Delivery 
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Copyright information

© The United States Government 2014

Authors and Affiliations

  1. 1.Center for Drug Evaluation and ResearchU.S. Food and Drug AdministrationSilver SpringUSA

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