Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin

Authors: Pasquiers B, Gualano V, Twarogowska M, Ayral G
Keywords: bioequivalence, compartmental analysis (CA), drug-drug interactions (DDIs), Food effects, MonolixSuite Playlist, noncompartmental analysis (NCA), pharmacokinetics, pkanalix feature
Software: Monolix®, PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

Need

Non-compartmental analysis (NCA) is used at all stages of drug development and is a key method to understand the pharmacokinetic properties of a compound. Bioequivalence analysis of the NCA parameters is a critical step to investigate generic formulations, food effects or drug-drug interactions.

Solution

PKanalix belongs to the MonolixSuite applications, and performs NCA and CA (compartmental analysis) and includes a bioequivalence module starting from the 2021 version.

Validation

As NCA and bioequivalence are commonly part of filings to the regulatory agencies, tools implementing these methods must be appropriately validated. For historical reasons, Phoenix WinNonLin is considered as the standard. In this work, we rigorously compare the results of PKanalix with those of WinNonLin.

By Blaise Pasquiers, Virginie Gualano, Monika Twarogowska, Géraldine Ayral