Deputy Division Director U.S. Food and Drug Administration Silver Spring, Maryland
Model informed drug development (MIDD) reflects the nature of application of exposure-based, biological and statistical models to facilitate drug development and decision making. It has been widely applied for dose selection, individualization, and optimization. In some situations, doses or dosing regimens may be determined by MIDD approaches without clinical efficacy and safety trials. This presentation is intended to provide some examples. We expect that MIDD can used to streamline new drug development and improve patient care in an efficient manner.
1. To understand the application of MIDD in dose selection, individualization, and optimization.
2. To understand the usage of MIDD in new drug development and health care.