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...
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| Published in | CPT: pharmacometrics and systems pharmacology Vol. 7; no. 2; pp. 82 - 89 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
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United States
John Wiley & Sons, Inc
01.02.2018
John Wiley and Sons Inc |
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| 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. |
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| AbstractList | 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. 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.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. |
| Author | Li, Mengyao Zhao, Ping Wagner, Christian Pan, Yuzhuo |
| AuthorAffiliation | 2 Merck & Co, Inc, Kennilworth New Jersey USA 5 Current affiliation: Merck KGaA Darmstadt Germany 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 4 Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration Silver Spring Maryland USA 3 Bill & Melinda Gates Foundation Seattle Washington USA |
| AuthorAffiliation_xml | – name: 3 Bill & Melinda Gates Foundation Seattle Washington USA – name: 4 Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration Silver Spring Maryland USA – name: 5 Current affiliation: Merck KGaA Darmstadt Germany – name: 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 – name: 2 Merck & Co, Inc, Kennilworth New Jersey USA |
| Author_xml | – sequence: 1 givenname: Mengyao surname: Li fullname: Li, Mengyao email: mengyao.li@merck.com organization: Merck & Co, Inc, Kennilworth – sequence: 2 givenname: Ping surname: Zhao fullname: Zhao, Ping organization: Bill & Melinda Gates Foundation – sequence: 3 givenname: Yuzhuo surname: Pan fullname: Pan, Yuzhuo organization: Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration – sequence: 4 givenname: Christian surname: Wagner fullname: Wagner, Christian organization: Current affiliation: Merck KGaA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29168611$$D View this record in MEDLINE/PubMed |
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| Copyright | 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. 2018. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Title | Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status |
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