Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds
The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus® was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption...
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| Published in | The AAPS journal Vol. 10; no. 1; pp. 213 - 226 |
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| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston
Springer US
2008
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| Subjects | |
| Online Access | Get full text |
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| Abstract | The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus® was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds. |
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| AbstractList | The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus® was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds. The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds. |
| Author | Langguth, Peter Tubic-Grozdanis, Marija Bolger, Michael B. |
| Author_xml | – sequence: 1 givenname: Marija surname: Tubic-Grozdanis fullname: Tubic-Grozdanis, Marija organization: Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University – sequence: 2 givenname: Michael B. surname: Bolger fullname: Bolger, Michael B. organization: Simulations Plus, Inc – sequence: 3 givenname: Peter surname: Langguth fullname: Langguth, Peter email: langguth@mail.uni-mainz.de organization: Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/18446522$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Beyond Guest Editors: James E. Polli Biochemistry Biological Availability Biomedical and Life Sciences Biomedicine Biopharmaceutics Classification System Biotechnology Computer Simulation Gastrointestinal Tract - drug effects Gastrointestinal Tract - metabolism Intestinal Absorption - drug effects Intestinal Absorption - physiology Permeability Pharmaceutical Preparations - metabolism Pharmacology/Toxicology Pharmacy Reproducibility of Results Research Article/Themed Issue: Bioequivalence Solubility Themed Issue: Bioequivalence, Biopharmaceutics Classification System, and Beyond Guest Editors: James E. Polli |
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| Title | Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds |
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