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PhinC | Corealis : Combining formulation expertise and predictive modeling
A strategic collaboration to integrate PBBM Modeling and PBPK modeling directly into oral solid dosage form development.
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 Model-Informed Drug Development (MIDD) and regulatory decision-making.
Navigating regulatory expectations in Model-Informed Drug Development
Longtemps cantonnée au rang d'approche expérimentale, la modélisation au service du développement du médicament (MIDD – Model-Informed Drug Development) s'impose aujourd'hui comme…
Avoiding Late-Stage Failure in Oncology Through MIDD
Late-stage attrition in oncology drug development represents a substantial scientific and economic inefficiency, with Phase III failure rates often exceeding 50%
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.
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.