An Integrated Approach to Mechanistically Model In Vitro Experiments and Incorporate Drug-specific Parameter Estimates within a PBPK Framework to Simulate In Vivo Drug Dissolution

Author(s): Shriram Pathak, Nikunjkumar Patel, Bo Liu, David Turner, Aaron Ruff, Edmund Kostewicz, Masoud Jamei

In vitro dissolution testing is a critical component of drug product development programs and is often used as a surrogate for in vivo performance. Consequently, mechanistic modelling of in vitro dissolution studies and informed data interpretation early in the formulation development process is crucial. The Simcyp In Vitro (Data) Analysis (SIVA) toolkit is a standalone module that contains a pre-defined library of mechanistic models for analysing in vitro data generated from different dissolution techniques such as USP II, USP IV, transfer model, two phase dissolution model etc. These modelling tools can be used to assess performance of models of in vitro experiments and, if required, re-visit input data (e.g., solubility, particle size), model assumptions and ultimately estimate unknown or uncertain parameters of the model.

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