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20 Mar 2022

What are the application of IVIVC?

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In vitro-in vivo correlation (IVIVC) models are having various applications. We are hereby listed IVIVC applications:

  • Product development of new formulations, pre-formulation studies, laboratory scale trials.
  • Optimization of the formulation/process predicted from the IVIVC validated.
  • During scale-up the dissolution data are used to judge the impact of process changes as well establishing final specifications for dissolution.
  • The database may possibly be utilized during further scale-up and site transfer as well as supporting post approval changes.
  • Analysis of in vitro and in vivo data for the feasibility of an acceptable IVIVC.
  • Design and analysis of clinical studies possibly needed for generating the IVIVC.
  • Aid in the optimization of in vitro dissolution system to be a predictor of in vivo performance, i.e. selection of a biorelevant and discriminating method.
  • Development and validation of Level A&C IVIVC models, including linear and nonlinear models.

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