title: Bioequivalence for locally acting nasal spray and nasal aerosol products: standard development and generic approval.
abstract: Demonstrating bioequivalence (BE) for nasal spray/aerosol products for local action has been very challenging because the relationship between the drug in systemic circulation and the drug reaching the nasal site of action has not been well established. Thus, the current BE standard for these drug/device combination products is based on a weight-of-evidence approach, which contains three major elements: equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition, formulation sameness and device similarity are evidences to support BE. This paper presents a comprehensive review of the scientific rationale of the current BE standard and their development history for nasal spray/aerosol products, as well as the Food and Drug Administration's review and approval status of generic nasal sprays/aerosols with the application of these BE standard.
authors.affiliation: Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA. bing.li@fda.hhs.gov
authors.forename: Bing V
authors.initials: BV
authors.lastname: Li
authors.forename: Feiyan
authors.initials: F
authors.lastname: Jin
authors.forename: Sau L
authors.initials: SL
authors.lastname: Lee
authors.forename: Tao
authors.initials: T
authors.lastname: Bai
authors.forename: Badrul
authors.initials: B
authors.lastname: Chowdhury
authors.forename: Hoainhon T
authors.initials: HT
authors.lastname: Caramenico
authors.forename: Dale P
authors.initials: DP
authors.lastname: Conner
mesh_terms: D000281:Administration, Intranasal; D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods*; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D006801:Humans; D059085:Nasal Sprays; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D059085:Nasal Sprays