title: International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences.
abstract: International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities and differences among these approaches used by international regulatory authorities when applications of generic and/or subsequent entry locally acting OIDPs are evaluated. We focused on four jurisdictions that currently have published related guidances for generic and/or subsequent entry OIDPs. They are Therapeutic Goods Administration (TGA) in Australia, Health Canada (HC) in Canada, European Medicines Association (EMA) of European Union (EU), and the Food and Drug Administration (FDA) in the United States of America (USA). The comparisons of these bioequivalence (BE) recommendations are based on selection of reference products, formulation and inhaler device comparisons, and in vitro tests and in vivo studies, including pharmacokinetic (PK), pharmacodynamics (PD), and clinical studies. For the in vivo studies, the study design, choices of dose, subject inclusion/ exclusion criteria, study period, study endpoint, and equivalence criteria are elaborated in details. The bioequivalence on multiple-strength products and waiver options are also discussed.
authors.affiliation: Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Dongmei
authors.initials: D
authors.lastname: Lu
authors.forename: Sau L
authors.initials: SL
authors.lastname: Lee
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lionberger
authors.forename: Stephanie
authors.initials: S
authors.lastname: Choi
authors.forename: Wallace
authors.initials: W
authors.lastname: Adams
authors.forename: Hoainhon N
authors.initials: HN
authors.lastname: Caramenico
authors.forename: Badrul A
authors.initials: BA
authors.lastname: Chowdhury
authors.forename: Dale P
authors.initials: DP
authors.lastname: Conner
authors.forename: Rohit
authors.initials: R
authors.lastname: Katial
authors.forename: Susan
authors.initials: S
authors.lastname: Limb
authors.forename: John R
authors.initials: JR
authors.lastname: Peters
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yu
authors.forename: Sally
authors.initials: S
authors.lastname: Seymour
authors.forename: Bing V
authors.initials: BV
authors.lastname: Li
mesh_terms: D000280:Administration, Inhalation; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000592:standards*; D004867:Equipment Design; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D009330:Nebulizers and Vaporizers; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards*; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations