Masoud Jamei

TL;DR: The mechanistic approach implemented in the Simcyp Simulator allows simulation of complex absorption, distribution, metabolism and excretion outcomes, particularly those involving multiple drug interactions, parent drug and metabolite profiles and time- and dose-dependent phenomena such as auto-induction and auto-inhibition.

TL;DR: An approach that incorporates intrinsic variability for human populations within a mechanistic framework is described together with examples of its application to drug and formulation development.

TL;DR: In this review, the classical 'top-down' approach in covariate recognition is compared with the 'bottom-up' paradigm and the commonly known tools for simulating ADME properties are introduced.

TL;DR: The predictive accuracy of the "well-stirred" gut model with the "Q(Gut)" model is compared and the former overpredicts the fraction escaping first-pass gut metabolism; the latter improves the predictions by accounting for interplay between permeability and metabolism.

TL;DR: It is expected that the "innovative" integration of in vitro data from more appropriate in vitro models and the enhancement of the GI physiology component of PBPK models, arising from the OrBiTo project, will lead to a significant enhancement in the ability of P BPK models to successfully predict oral drug absorption and advance their role in preclinical and clinical development, as well as for regulatory applications.