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. 2021 Mar 9;10(5):399–411. doi: 10.1002/psp4.12600

TABLE 2.

Observed and predicted plasma diclofenac Cmax and AUC following the application of the application of the reference and the test drug product

Parameter R T
Cmax, ng/ml AUC, ng·hr/ml Cmax, ng/ml AUC, ng·hr/ml
Predicted/observed ratio 0.82 1.77 0.70 1.74

Predictions were generated leveraging dermal physiologically‐based pharmacokinetic models developed for Voltaren topical gel, 1% (reference) and its genetic (test).

Abbreviations: AUC, area under the concentration/amount curve from time zero to the last measurable concentration; Cmax, maximum concentration; R, reference drug product; T, test drug product.