Michael Bewernitz, Anantha Ram Nookala, Gopichand Gottipati, Praveen Balimane, Venkateswaran C Pillai, Jeffry Florian, Adarsh Gandhi, Kevin Krudys, David Lee, Dawei Li, Min Li, Zhihua Li, Jie Liu, Rajanikanth Madabushi, Grimstein Manuela, Mehul Mehta, Srikanth C Nallani, Nimishraj Panse, Wei Qiu, Sreedharan Sabarinath, Vishnu Sharma, Li Tan, Ramana Uppoor, Yun Xu, Hao Zhu, Venkatesh Atul Bhattaram
Model-informed drug development (MIDD) approaches are being increasingly used in neuroscience drug development programs and regulatory decision-making. In this work, the authors summarize a select set of cases in neurology, psychiatry, addiction, anesthesia, and analgesia, where MIDD approaches were utilized to address critical drug development questions or fill knowledge gaps. These examples include efficacy considerations such as biomarker-clinical endpoint relationships, surrogate endpoints for accelerated approval, extrapolation of efficacy, and safety aspects such as informing driving studies. Additionally, the examples also inform optimal dosing regimen selection, dose adjustments in drug interactions, life cycle management decisions such as indication expansion, formulation switching, and informing patient population selection. Together, these examples offer insights into the utility of MIDD approaches to streamline drug development and opportunities to save costs and resources.