PQRI Workshop Report: Application of IVIVC in Formulation Development
Dissolution technologies(2014)
摘要
This article summarizes the proceeding of the September 2012 Workshop on Application of In vitro In vivo correlation (IVIVC) in Formulation Development. The workshop brought together international experts with the goal of establishing common concepts that could be utilized to facilitate the development and validation of IVIVCs in the registration of and post-approval changes to oral solid dosage forms. The workshop was organized by the Product Quality Research Institute (PORI) and cosponsored by AAPS, FDA, FIP, and USP. Open access of this information is available to all interested parties.
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