Abstract

The conventional route for drug discovery and development is a costly and time-consuming process. Many initiatives, such as the Critical Path Initiative, have been launched to encourage the use of mathematical, statistical, and computational tools in the drug development and regulatory review process, paving the way for the Model-Informed Drug Discovery and Development pathway. These tools enable the identification of a lead candidate having the right mix of pharmacokinetic, pharmacodynamic, and biopharmaceutical properties with high probability of success.

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