Pharmacokinetic (PK) data programming in {admiral} and the Pharmaverse

Abstract

Pharmacokinetic (PK) analysis data programming poses some unique challenges. For example, both dosing and concentration records are included, and nominal and actual relative time variables that reference the first dose, the previous dose, or the next upcoming dose are required. Modelling data may require a number of numeric covariates. CDISC ADaM submission standards for Non-compartmental Analysis (ADNCA) data have recently been published, and new standards for Population PK (ADPPK) are forthcoming. admiral is an open-source R package for creating CDISC ADaM data. It can be used effectively to create both types of PK analysis data. Additional tools from other Pharmaverse packages such as metacore and metatools can be used to simplify the workflow. I will discuss some of the challenges of Pharmacokinetic data programming and show some of the solutions developed in admiral and the Pharmaverse.

Type
Publication
Presented at 2023 Conference