Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Authors: Yang K
Conference: Discovery Toxicology
Software: DILIsym®

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

Authors: Yang K
Conference: Drug-Induced Liver Injury Conference
Software: DILIsym®

Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI

From Preclinical to Clinical Drug Product Development:​ A Path for Smooth Transition

From Preclinical to Clinical Drug Product Development:​ A Path for Smooth Transition

Authors: Suarez-Sharp S
Conference: AAPS
Division: PBPK

It is challenging to establish a standard approach for moving from preclinical to clinical phases of development. Many hurdles exist during formulation selection and for extrapolation of doses from animals to humans; what may have worked well for one drug candidate may not be appropriate for others. This presentation will provide a general framework/strategy to follow when moving from preclinical to clinical studies (FIH) based on risk identification and mitigation focusing on the application of mechanistic modeling and simulation (PBPK)​.