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 “dissolution safe space” based on the bio batch dissolution specifications. The Sponsor had performed a BA BE study and 90% CI is within the range of 80% – 125%.
Could Modeling and Simulation establish a dissolution safe space without conducting actual BA BE study?
BA BE data of the test product and the reference were used in the analysis.
The in-silico dissolution safe space was established by means of IVIVC modeling followed by virtual BE
A validated IVIVC model (see figure) was developed and used to simulate the “Dissolution Safe Space”.
| Spec. | Limits |
| 1 h | 10 – 30% |
| 6 h | 35 – 65% |
| 18 h | NLT 75% |
| Drug Record | Cmax (ng/mL) | AUC (ng/mL*h) | ||||
| Obs. | Pred. | % Pred. Error | Obs. | Pred. | % Pred. Error | |
| Pivotal – Test sample | 2058 | 2143 | -4.13 | 1.39E+05 | 1.38E+05 | 0.217 |
| Pivotal – Reference standard (Trokendi XR®) | 2283 | 2495 | -9.286 | 1.44E+05 | 1.39E+05 | 3.199 |
| Specifications | Proposed Limits | |||||
| 1 h | 10 – 30% | |||||
| 6 h | 35 – 65% | |||||
| 18 h | NLT 75% | |||||
The Agency accepted the Sponsor’s M&S methodology including the “Dissolution Safe Space” proposal.
The Sponsor reduced costs and timelines for the commercial batches by having wider dissolution specifications for batch release.
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