The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of modeling & simulation software for regulatory purposes. Concepts of quality, data reproducibility, model qualification (model credibility), and modeling acumen are explored for both commercial and open source tools. In this event, Dr. Amin Rostami, key author of the paper framed and analyzed the issues surrounding the structure and set-up of these tools, pros and cons, and outlined a path forward.
