• Publication Date: 12/01/2016
  • Author(s):
    Mitchell, Jolyon P.
  • Organization(s):
    Jolyon Mitchell Inhaler Consulting Services, Inc.
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Instruments, Particle Characterization, Product Development/Formulation, Quality by Design (QbD), Testing, Validation, and Regulatory Compliance
Testing for dose content uniformity and aerodynamic particle size distribution has shifted from pharmacopeial quality control testing to more clinically appropriate methods.

This article looks at the noticeable shift from standard pharmacopeial quality control testing to more realistic end-user-driven testing by incorporating clinically appropriate methods. It also looks into development of more advanced technologies for OIP-generated particle size distribution assessment. Finally, it briefly mentions testing of APSD for OIPs containing formulations that incorporate nanoparticles.

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