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The AAPS Journal

, Volume 15, Issue 3, pp 875–883 | Cite as

Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

  • Bing V. LiEmail author
  • Feiyan Jin
  • Sau L. Lee
  • Tao Bai
  • Badrul Chowdhury
  • Hoainhon T. Caramenico
  • Dale P. Conner
Regulatory Note

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.

Key words

bioequivalence generic locally acting drug nasal aerosol nasal spray 

References

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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  • Bing V. Li
    • 1
    Email author
  • Feiyan Jin
    • 2
  • Sau L. Lee
    • 2
  • Tao Bai
    • 1
  • Badrul Chowdhury
    • 3
  • Hoainhon T. Caramenico
    • 1
  • Dale P. Conner
    • 1
  1. 1.Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and ResearchFood and Drug AdministrationRockvilleUSA
  2. 2.Division of Chemistry, Office of Generic Drugs, Center for Drug Evaluation and ResearchFood and Drug AdministrationRockvilleUSA
  3. 3.Division of Pulmonary, Allergy, and Rheumatology Products, Office of Drug Evaluation, Office of New Drugs, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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