PBBM: connecting drug product performance to clinical outcomes
Physiologically Based Biopharmaceutics Modeling (PBBM) is no longer a peripheral, exploratory tool and has emerged as a central pillar in modern formulation development and an increasingly important component of MIDD and regulatory decision-making.
A guide to the FDA announcement to phase out animal testing
The landscape of preclinical drug development is undergoing a paradigm shift driven by the need for more human-relevant evidence and a global regulatory movement toward ethical safety testing.
Dose optimization in oncology: a hidden MIDD challenge in the era of project Optimus
For decades, oncology followed a simple principle: administer the maximum tolerated dose. With modern therapies, this paradigm no longer holds — discover how MIDD addresses the FDA's new Project Optimus expectations.
10 good reasons to use Modeling and Simulation in your drug development
Modeling expertise is an essential cornerstone for a robust and optimal drug development strategy.
FDA announces plan to phase out animal testing requirement for mAbs and other drugs
The FDA is taking a groundbreaking step to advance public health by replacing animal testing in the development of mAbs therapies and other drugs.
MIDD and FDA: What Biotechs need to know about ICH M15
The ICH M15 guidance introduces a harmonized framework that allows these models to be formally recognized as “MIDD evidence” by regulatory authorities such as the FDA.