TABLE 4.
Summary of bioequivalence assessment results performed leveraging the simulated plasma and synovial fluid PK profiles generated with the dermal PBPK models developed for the R and T drug products
| Parameter | R | T | N | Ratio | Lower 90% PI | Upper 90% PI |
|---|---|---|---|---|---|---|
| Plasma | ||||||
| Cmax, ng/ml | 5.87 | 5.56 | 78 | 0.90 | 81.29 | 98.77 |
| AUC, ng·hr/ml | 638.40 | 630.56 | 78 | 0.98 | 88.63 | 107.39 |
| Synovial fluid | ||||||
| Amax, μg | 230.13 | 222.47 | 78 | 0.93 | 85.06 | 102.68 |
| AUC, μg·hr/ml | 37,888.28 | 37,362.20 | 78 | 0.97 | 87.7 | 107.83 |
Predictions were generated leveraging dermal PBPK models developed for Voltaren topical gel, 1% (reference) and its genetic (test).
Abbreviations: Amax, maximum amount in the tissue; AUC, area under the concentration/amount curve from time zero to the last measurable concentration; Cmax, maximum concentration; PBPK, physiologically‐based pharmacokinetic; PK, pharmacokinetic; PI, prediction interval; N, sample size; R, reference drug product; T, test drug product.