Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics

JournalMIDDPharmacometricsRegulatory interactions

Introduction

Read this publication to learn about the advantages of using automation tools when producing reports of complex pharmacometric analyses in the drug development process.

Significance

In an attempt to take a snapshot of the landscape of tools currently available to medical writers, the European Medical Writing Association (EMWA) created an entire issue of the
journal on the topics of Artificial Intelligence (AI) and Machine Learning (ML).

Pharmetheus contributes with this new publication describing the integration of open-source software into a robust process that allows summarizing and reporting input and output data of pharmacometric analysis. The reproducible reporting system described in this article increases automation, traceability, and standardization of reports that are used for drug development and regulatory assessment.