External qualification of the Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) models for octocog alfa using real patient data.

ABSTRACT:

Background

Existing adult patient pharmacokinetic (PK) data from the published Advate vs Kovaltry PK crossover study were used for this validation study. This data set is appropriate for qualification, given that it has not been previously submitted to Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) and will not have impacted the WAPPS-Hemo models for Kovaltry.

Objective

To compare the population PK parameters for Kovaltry (BAY 81-8973) derived from the WAPPS-Hemo models with PK parameters derived from noncompartmental analysis (NCA), using a validation PK dataset.

Methods

The qualification data set included Kovaltry factor activity (10 samples per infusion) and anthropometric data for 18 patients. Two analyses were performed comparison of Ba

SUBMITTER: Chelle P 

PROVIDER: S-EPMC8563921 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature