• Publication Date: 06/01/2009
  • Author(s):
    Suman, Julie D.
  • Organization(s):
    Next Breath
  • Article Type: Technical Articles
  • Subjects: Nasal Delivery, Testing, Validation, and Regulatory Compliance
When to perform spray characterization tests in the development cycle of a nasal spray product.

While the relationship between certain spray characteristics and the therapeutic effect of a product is still under investigation, the FDA currently requires numerous techniques for characterizing the nasal spray drug product for New Drug Applications (NDAs). Submissions of Abbreviated New Drug Applications (ANDAs) also require a subset of these tests to demonstrate in vitro bioequivalence for locally-acting nasal sprays. This article discusses the optimum timing of spray characterization studies during nasal spray product development.

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