Oral docetaxel plus encequidar – A pharmacokinetic model and evaluation against IV docetaxel

Conclusion: The study demonstrates the benefits of MIDD using oDox + E as a mot ivating example. A population pharmacokinetic model was developed for the total and unbound concentration in plasma of docetaxel after administration of IV docetaxel and oDox + E. The model was used to simulate oDox + E dose regimens which were compared to the current standard of care IV doc etaxel regimen. A GO / NO-GO framework was applied to determine whether oDox + E should progress to the next phase of drug development and whether any conditions should apply. A two or three-dose regimen of oDox + E at 600 mg was able to achieve non-inferior pharmacokinetic exposure to curr ent standard of care IV docetaxel in simulations. A Conditional GO decision was made based on this result and further quantification of the “effective concentration” would improve the ability to optimise the dose regimen.
Source: Journal of Pharmacokinetics and Pharmacodynamics - Category: Drugs & Pharmacology Source Type: research