Selected engagements illustrating how KinetiX modeling science translates into confident regulatory decisions and accelerated development timelines.
PBBM and Virtual BE modeling allowed the team to evaluate 12 formulation scenarios without a single clinical study, shortlisting two candidates for confirmatory BE.
12
Scenarios modeled
60%
Timeline reduction
0
Clinical studies required for shortlisting
An IVIVE-PBPK workflow translated preclinical absorption and clearance data into confident FIH exposure predictions, enabling regulatory submission with a robust scientific rationale.
3
Species extrapolated
94%
Prediction accuracy vs. observed
1
Regulatory submission supported
Level A IVIVC development connected in vitro dissolution profiles to in vivo PK performance, enabling science-based specification setting and reducing regulatory risk.
Level A
IVIVC established
3
Formulation strengths covered
100%
Regulatory acceptance