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Risk management for combination products

  • Publication Date: 10/01/2009
  • Author(s):
    Brouet, Guillaume Chesworth, Tim Christopher, David Hart, John Lafferty, Paul Lyapustina, Svetlana
  • Organization(s):
    AstraZeneca Drinker Biddle & Reath Pfizer Quintiles Consulting Schering-Plough Valois
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Testing, Validation, and Regulatory Compliance
The need for improved risk management practices for orally inhaled and nasal drug products.

Currently, no harmonized guidelines for development of combination products exists; however, developing an early understanding of the relationships between a particular formulation and a particular device can minimize the need for changes or can streamline implementation of changes in late product development and post-approval. In order to assist the industry in achieving these goals, a working group of IPAC-RS has studied the contrasting approaches to regulation and design control for these types of projects.

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