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Quality by design

  • In: S1 - Dissolution testing: A pivotal tool for development and quality of drugs on Monday, 3 September 2007, 9:00-12:00
  • At: Beijing (China) (2007)
  • Type: Presentation
  • By: BUHSE, Lucinda (FDA, St. Louis, United States of America)
  • Abstract:

    The US FDA’s new science and risk-based pharmaceutical quality assessment system (PQAS) is based on principles of Quality by Design (QbD) that will promote a more scientific approach to quality assurance through product and process understanding. A thorough understanding of which process parameters and raw material characteristics affect


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Last update 28 September 2023

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