Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status

A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect pred...

Full description

Saved in:
Bibliographic Details
Published inCPT: pharmacometrics and systems pharmacology Vol. 7; no. 2; pp. 82 - 89
Main Authors Li, Mengyao, Zhao, Ping, Pan, Yuzhuo, Wagner, Christian
Format Journal Article
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.02.2018
John Wiley and Sons Inc
Subjects
Bioavailability
Data collection
Enzymes
Food
Permeability
Pharmaceuticals
Pharmacokinetics
Physiology
Review
Reviews
Software
Studies
United States > US
Online AccessGet full text

Cover

More Information
Summary:A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect predictions, ∼50% were predicted within 1.25‐fold of observed, and 75% within 2‐fold. Dissolution rate and precipitation time were commonly optimized parameters when PBPK modeling was not able to capture the food effect. The current work presents a knowledgebase for documenting PBPK experience to predict food effect.
Bibliography:A part of this work was presented in poster form at the American Society for Clinical Pharmacology and Therapeutics 2017 Annual Meeting, Washington, DC, March 15–18, 2017.
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Review-3
content type line 23
ISSN:2163-8306
2163-8306
DOI:10.1002/psp4.12260