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10 good reasons to use Modeling and Simulation in your drug development
Modeling expertise is an essential building block for an optimal drug development strategy.
Publication: Development of a PBPK Model for ADC (oncology)
A first-in-class PBPK model for CLDN18.2-targeted ADCs using PK-Sim® and MoBi®. Read and discover the full article!
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…
Modeling & Simulation integrated in drug development
Modeling and simulation play an increasingly crucial role in the development of drug candidates.
New article: Unlock the power of PBPK Prediction!
In the ever-evolving landscape of pharmaceutical research, the quest for developing safer and more effective drugs is a continuous endeavor.
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.