Journal
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY
Volume 7, Issue 2, Pages 82-89Publisher
WILEY
DOI: 10.1002/psp4.12260
Keywords
-
Categories
Funding
- Center for Drug Evaluation and Research
- US Department of Energy
- FDA
Ask authors/readers for more resources
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, similar to 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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available