Dose Selection Based on Physiologically Based Pharmacokinetic (PBPK) Approaches

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

The US Food and Drug Administration (FDA) public workshop, entitled "Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and pr...

Proposed Approach to Efficiently Develop Physiologically Based Pharmacokinetic (PBPK) & Physiologically Based Pharmacokinetic-Pharmacodynamic (PBPK-PD) Models for Pesticides

The standard approach to extrapolating from animals to humans (inter-species) or across the human population (intra-species) in risk assessment is to apply 10X uncertainty factors. In Science and Decisions: Advancing Risk Assessment (NRC, 2009), the NAS recommends that the agency “...continue and expand use of the best, most current science to support and revise default assumptions.” EPA publis...

Physiologically Based Pharmacokinetic (PBPK) model for biodistribution of radiolabeled peptides in patients with neuroendocrine tumours

Objective(s): The objectives of this work was to assess the benefits of the application of Physiologically Based Pharmacokinetic (PBPK) models in patients with different neuroendocrine tumours (NET) who were treatedwith Lu-177 DOTATATE. The model utilises clinical data on biodistribution of radiolabeled peptides (RLPs) obtained by whole body scintigraphy (WBS) of the patients.Methods: The blood...

A Physiologically Based Pharmacokinetic ( PBPK ) 1 Model of Vitamin D

Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation