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

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work.