Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.

ABSTRACT: The objectives of this analysis were to develop a population pharmacokinetic model (PPK) for tenofovir without using potentially unreliable patient reported dosing records and to retrace patient dosing history using pharmacokinetic simulations conditioned on protocol design constraints to assess patient adherence. MTN-001 is a multi-center, open label, 3-way cross over study comparing oral, vaginal and combination (oral and vaginal) administration of tenofovir in healthy women. It was reported that self-reported adherence in this study was high (94%), but serum concentrations indicated only 64% of participants used tablets consistently. A method based on superposition was applied to develop the population PPK considering only observable clinic visit dosing information. A two compartment mo

SUBMITTER: Chaturvedula A 

PROVIDER: S-EPMC5001555 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature