In Silico Bioequivalence – to replace clinical trial
In silico SD Bioequivalence trial to replace clinical trial
In silico SD Bioequivalence trial to replace clinical trial
The Sponsor intended to have a biowaiver for the non-proportional lower strength. The Sponsor had performed a BA BE study with the higher strength.
Could Modeling and Simulation replace the BA BE trial by an in silico BA BE?
BA BE data of the higher strength and PK data of the reference for the lower strength were used in the analysis.
The in-silico BA BE trial was performed by means of IVIVC modeling.
A validated IVIVC model (see figure) was developed and used to simulate the BA BE trial.
· The Agency accepted the Sponsor’s clinical development program including the in silico BA BE study.
· The Sponsor reduced costs and timelines by waiving off the BA BE study for lower strengths.
In silico Quantitative Structure-Toxicity Relationship (QSTR) Model for Predicting Toxicity of Aromatic Aldehydes using Extended Topochemical Atom (ETA) Indices.
In silico SD Bioequivalence trial to replace clinical trial
In silico clinical trial to support label extension.
Connect with our in silico team of experts to discuss AI solutions and advanced modeling and simulation for the Pharma and Life Science industries and hyper accelerate your success
Our Locations
Copyrights 2024 Ikiminds Pvt Ltd. All Rights Reserved