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Quality by Design for Particulate Systems

  • Anthony J. Hickey
  • Stefano Giovagnoli
Chapter
Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)

Abstract

The foregoing sections described the methods of manufacturing and characterization of pharmaceutical particulate systems. Scrutiny of these systems defines key physicochemical properties establishing their quality as a preliminary to inclusion in a dosage form. This is fundamental to monitoring and control of critical properties of these systems with a view to optimization and establishing quality by design. The use of statistical experimental design during optimization and statistical process control during manufacturing allows the production of the dosage form to meet the target product profile within narrow limits that assure its uniformity. Ultimately, assuring the quality translates into a safe and efficacious drug product.

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Anthony J. Hickey
    • 1
  • Stefano Giovagnoli
    • 2
  1. 1.Discovery Science and TechnologyRTI InternationalResearch Triangle ParkUSA
  2. 2.Department of Pharmaceutical SciencesUniversity of PerugiaPerugiaItaly

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