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Application of dissolution testing to regulatory approval in EU

  • In: C6 - Understanding the Dissolution Testing and IVIVC on Monday, 7 September 2009, 9:00-12:00
  • At: Istanbul (Turkey) (2009)
  • Type: Presentation
  • By: BARENDS, Dirk (RIVM, Bilthoven, Netherlands)
  • Abstract:

    The European Pharmacopoeia only contains a general chapter on dissolution testing, no monographs on specific drug products. So, in the EU, pharmaceutical companies are free to propose the release dissolution method for their drug product, taking into account scientific soundness. For drug products containing new drug substances, the dissolution

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Last update 28 September 2023

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