• Publication Date: 12/01/2009
  • Author(s):
    Brouet, Guillaume Chesworth, Tim Christopher, David Hart, John Lafferty, Paul Lyapustina, Svetlana
  • Organization(s):
    AstraZeneca Drinker Biddle & Reath Merck Pfizer Quintiles Consulting Valois
  • Article Type: Technical Articles
  • Subjects: Testing, Validation, and Regulatory Compliance
International approaches to regulation and quality standards for orally inhaled and nasal drug products.

Drug-device combination products such as OINDPs that share both drug and device attributes, present particular challenges in the application of regulations by various authorities around the world. An understanding and awareness of the approaches to these types of products by various authorities can facilitate design development and control of OINDPs, as well as helping companies evaluate the benefits of marketing a product first in one region or another.

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