Abstract

Biosimilar development is crucial to making lifesaving treatments more affordable and accessible to patients—and researchers are under increasing pressure to reduce cost and time without compromising scientific rigor. In this video, you will learn how model-informed simulations can guide key design decisions in biosimilar development. Stephanie Kollmann, Associate Product Specialist at Simulations Plus, covers how to formulate dosing recommendations and identify optimal study size in MonolixSuite™, using pegfilgrastim as a case study and a published population PKPD model of the marketed reference product to simulate clinical scenarios for a hypothetical biosimilar. See how Simulx® and PKanalix® work seamlessly together to streamline your work and provide predictions for critical decisions, as well as have the chance to ask questions during the live Q&A.