Stage 5: Model Development, Data Collection, and Credibility Planning

In accordance with previous EMA, ICH, ISO, ASME and ISPE guidance (ASME, 2018; EMA, 2024; ICH Q13; ISPE GAMP; ISO/IEC 5259), the computational model should be developed and calibrated using the planned datasets. In parallel, a credibility assessment plan should be established specifying which credibility factors (e.g. code verification, solution verification, validation against experimental data, uncertainty quantification) will be addressed and to what extent.