This webinar will explore how model-informed drug development (MIDD) techniques are being used to support regulatory approval of new products through the 505(b)(2) pathway. Through detailed case studies, learners will gain practical insight into how the US Food & Drug Administration has accepted model-based justifications for dosing, safety and efficacy, using examples involving fixed-dose combinations, high-potency opioid antagonists and dose optimization in renal or hepatic impairment. Learners that complete this event will understand the significance of model-informed approaches in drug development and regulatory decisions associated with 505(b)(2) submissions.

This webinar will explore how PK bridging is a cornerstone of successful formulation changes, with a specific focus on IV to SC transitions. Industry and regulatory experts will examine how the PK landscape has evolved and share practical, forward-looking strategies—including model-informed drug development approaches—to address the complexities of bridging. Real-world case studies will provide insight into what has worked, what hasn’t, and why. Whether you're in early development or managing a late-stage formulation shift, this session will equip you with the scientific, regulatory and strategic knowledge needed to implement effective PK bridging and streamline development. Attendees will gain a clear understanding of when PK bridging is essential, how to recognize key decision points and what tools and cross-functional perspectives are shaping the future of route transition in drug development. Learners who complete this activity will have enhanced knowledge in the use of PK bridging strategies in therapeutic drug monitoring.

The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.

Drug-induced nephrotoxicity (DIN) is a major clinical challenge for a variety of marketed drugs belonging to various therapeutic areas. Successful clinical prevention of DIN requires prior knowledge of drug’s mechanism of action coupled with pathogenic mechanisms of renal injury as well as patient- and drug-related risk factors. Recently, significant innovative advances in the identification of novel early biomarkers for DIN have been made. However, they are not beyond limitations. In such scenarios, mathematical modeling and simulation (M&S) may be used as a robust tool to understand and predict DIN in a clinical setting. This presentation highlights some of the recent advancements in mathematical M&S approaches for DIN. An example of the utility of multiscale and translational M&S for combinatorial effects of a DIN with a proposed preventive therapeutic will be showcased.