MIDD: stop guessing, start modeling.

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

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!

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.