Mechanistic models, i.e. mathematical or computer models that integrate biopharmaceutical, physico mechanical, (patho)physiological and pharmacological processes, along with population characteristics, are frequently and increasingly used in all phases of the drug research and development life cycle. A new guideline on the assessment and reporting of these models is needed. Mechanistic models covered by this new guideline include, but are not limited to, Physiologically Based Pharmacokinetic (PBPK), Physiologically Based Biopharmaceutics (PBBM) and Quantitative Systems Pharmacology (QSP) models.
