Open AccessConsideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation
Author(s) -
Kuemmel Colleen,
Yang Yuching,
Zhang Xinyuan,
Florian Jeffry,
Zhu Hao,
Tegenge Million,
Huang ShiewMei,
Wang Yaning,
Morrison Tina,
Zineh Issam
Publication year - 2020
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12479
Subject(s) - credibility , risk analysis (engineering) , drug development , variety (cybernetics) , computer science , management science , drug , engineering ethics , process management , medicine , business , pharmacology , political science , engineering , artificial intelligence , law
The use of computational models in drug development has grown during the past decade. These model‐informed drug development (MIDD) approaches can inform a variety of drug development and regulatory decisions. When used for regulatory decision making, it is important to establish that the model is credible for its intended use. Currently, there is no consensus on how to establish and assess model credibility, including the selection of appropriate verification and validation activities. In this article, we apply a risk‐informed credibility assessment framework to physiologically‐based pharmacokinetic modeling and simulation and hypothesize this evidentiary framework may also be useful for evaluating other MIDD approaches. We seek to stimulate a scientific discussion around this framework as a potential starting point for uniform assessment of model credibility across MIDD. Ultimately, an overarching framework may help to standardize regulatory evaluation across therapeutic products (i.e., drugs and medical devices).