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 modify the formulation composition based on the failed bioequivalence study. The Sponsor had performed a BA BE study and 90% CI was not within the range of 80% – 125%.
Could Modeling and Simulation propose a formulation composition (Q1 & Q2) which can be bioequivalent with the RLD?
BA BE data of the test product and the reference were used in the analysis.
The in-silico BA BE prediction was performed by means of IVIVC modeling followed by virtual BE
| Drug Record | Cmax (ng/mL) | AUC (ng/mL*h) | Observed T/R | Predicted T/R | ||||||
| Obs. | Pred. | % Pred. Error | Obs. | Pred. | % Pred. Error | Cmax | AUC | Cmax | AUC | |
| Lidoderm | 38.06 | 41.2 | -8.235 | 484.8 | 415 | 14.39 | – | – | – | – |
| T2 | 22.79 | 27.09 | -18.91 | 304.4 | 340.5 | -11.86 | 0.60 | 0.63 | 0.66 | 0.82 |
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.
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