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CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):82-89. doi: 10.1002/psp4.12260. Epub 2017 Nov 23.

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

Li M1,2, Zhao P1,3, Pan Y4, Wagner C1,5.

Author information

1
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
2
Merck & Co, Inc, Kennilworth, New Jersey, USA.
3
Bill & Melinda Gates Foundation, Seattle, Washington, USA.
4
Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
5
Current affiliation: Merck KGaA, Darmstadt, Germany.

Abstract

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.

PMID:
29168611
PMCID:
PMC5824104
DOI:
10.1002/psp4.12260
[Indexed for MEDLINE]
Free PMC Article

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