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MIDD: stop guessing, start modeling.
MIDD transforms drug development: predictive modeling, optimized dose selection, and stronger regulatory dialogue — from the earliest stages of development.
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.