The Sponsor intended to have a bio-predictive media followed by IVIVR model to predict the plasma exposure for different in-vitro release and different doses. The Sponsor had performed a pre-clinical study on the higher strength.
PK sparse sampling scheme optimization for phase III clinical trial in Oncology
The Sponsor intended to have a bio-predictive media followed by IVIVR model to predict the plasma exposure for different in-vitro release and different doses. The
Enhancing the efficacy of a COVID-19 Vaccine
In silico MD clinical trial in children 12-18 years of age
The Sponsor intended to have a “dissolution safe space” based on the bio batch dissolution specifications. The Sponsor had performed a BA BE study and
Augmenting Tuberculosis clinical trials with a Synthetic Arm
In Silico trial to optimize formulation composition of transdermal patch for achieving bioequivalence
In Silico trial to replace Bioequivalence trial for formulation with different particle size distribution (PSD)
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