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Food, gastrointestinal pH, and models of oral drug absorption.
Abuhelwa AY, Williams DB, Upton RN, Foster DJ. Abuhelwa AY, et al. Eur J Pharm Biopharm. 2017 Mar;112:234-248. doi: 10.1016/j.ejpb.2016.11.034. Epub 2016 Nov 30. Eur J Pharm Biopharm. 2017. PMID: 27914234 Review.
This article reviews the major physiological and physicochemical principles of the effect of food and gastrointestinal (GI) pH on the absorption and bioavailability of oral drugs, and the various absorption models that are used to describe/pr …
This article reviews the major physiological and physicochemical principles of the effect of food and gastrointestinal …
Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status.
Li M, Zhao P, Pan Y, Wagner C. Li M, et al. CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):82-89. doi: 10.1002/psp4.12260. Epub 2017 Nov 23. CPT Pharmacometrics Syst Pharmacol. 2018. PMID: 29168611 Free PMC article. Review.
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 foo …
A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether …
Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection.
Gajewska M, Blumenstein L, Kourentas A, Mueller-Zsigmondy M, Lorenzo S, Sinn A, Velinova M, Heimbach T. Gajewska M, et al. AAPS J. 2020 Oct 18;22(6):134. doi: 10.1208/s12248-020-00511-7. AAPS J. 2020. PMID: 33070288
A physiologically based pharmacokinetic (PBPK) human model for alpelisib, an oral alpha-specific class I phosphatidylinositol-3-kinase (PI3K) inhibitor, was established to simulate oral absorption and plasma pharmacokinetics of hea …
A physiologically based pharmacokinetic (PBPK) human model for alpelisib, an oral alpha-specific class I …
Physiologically-Based Pharmacokinetic Modeling to Predict the Clinical Efficacy of the Coadministration of Lopinavir and Ritonavir against SARS-CoV-2.
Thakur A, Tan SPF, Chan JCY. Thakur A, et al. Clin Pharmacol Ther. 2020 Dec;108(6):1176-1184. doi: 10.1002/cpt.2014. Epub 2020 Oct 6. Clin Pharmacol Ther. 2020. PMID: 32767755 Free PMC article.
We built a physiologically-based pharmacokinetic model of lopinavir/ritonavir in white and Chinese populations. Our aim was to perform pharmacokinetic/pharmacodynamic correlations by comparing simulated free plasma and lung concentration …
We built a physiologically-based pharmacokinetic model of lopinavir/ritonavir in white and Chinese populations. …
Integration of dissolution into physiologically-based pharmacokinetic models III: PK-Sim.
Willmann S, Thelen K, Lippert J. Willmann S, et al. J Pharm Pharmacol. 2012 Jul;64(7):997-1007. doi: 10.1111/j.2042-7158.2012.01534.x. Epub 2012 May 16. J Pharm Pharmacol. 2012. PMID: 22686345
Among the various computational methods available, physiologically-based pharmacokinetic (PBPK) modelling represents a well-established tool for mechanistically predicting the pharmacokinetics of drugs and drug candidates. ...In th …
Among the various computational methods available, physiologically-based pharmacokinetic (PBPK) modelling repres …
Physiologically Based Pharmacokinetic Modeling Approach to Identify the Drug-Drug Interaction Mechanism of Nifedipine and a Proton Pump Inhibitor, Omeprazole.
Le Merdy M, Tan ML, Sun D, Ni Z, Lee SC, Babiskin A, Zhao L. Le Merdy M, et al. Eur J Drug Metab Pharmacokinet. 2021 Jan;46(1):41-51. doi: 10.1007/s13318-020-00649-x. Eur J Drug Metab Pharmacokinet. 2021. PMID: 33064292
RESULTS: The developed PBPK model properly described the pharmacokinetics of nifedipine and predicted the inhibitory effect of multiple-dose omeprazole on CYP3A4 activity. With the incorporation of the physiologic effect of omeprazole on …
RESULTS: The developed PBPK model properly described the pharmacokinetics of nifedipine and predicted the inhibitory …
Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review.
Guimarães M, Statelova M, Holm R, Reppas C, Symilllides M, Vertzoni M, Fotaki N. Guimarães M, et al. J Pharm Pharmacol. 2019 Apr;71(4):603-642. doi: 10.1111/jphp.12955. Epub 2018 Jul 3. J Pharm Pharmacol. 2019. PMID: 29971768 Review.
The usefulness of computational simulation and modeling for extrapolation of adult data to paediatrics has been confirmed as a tool for predicting drug formulation performance. Despite the great number of successful physiologically based …
The usefulness of computational simulation and modeling for extrapolation of adult data to paediatrics has been confirmed as a tool f …
Development of a physiologically based model to describe the pharmacokinetics of methylphenidate in juvenile and adult humans and nonhuman primates.
Yang X, Morris SM, Gearhart JM, Ruark CD, Paule MG, Slikker W Jr, Mattison DR, Vitiello B, Twaddle NC, Doerge DR, Young JF, Fisher JW. Yang X, et al. PLoS One. 2014 Sep 3;9(9):e106101. doi: 10.1371/journal.pone.0106101. eCollection 2014. PLoS One. 2014. PMID: 25184666 Free PMC article.
The widespread usage of methylphenidate (MPH) in the pediatric population has received considerable attention due to its potential effect on child development. For the first time a physiologically based pharmacokinetic (PBPK) model has been deve …
The widespread usage of methylphenidate (MPH) in the pediatric population has received considerable attention due to its potential effect …
The use of modeling tools to drive efficient oral product design.
Mathias NR, Crison J. Mathias NR, et al. AAPS J. 2012 Sep;14(3):591-600. doi: 10.1208/s12248-012-9372-3. Epub 2012 May 30. AAPS J. 2012. PMID: 22644702 Free PMC article. Review.
Modeling and simulation of drug dissolution and oral absorption has been increasingly used over the last decade to understand drug behavior in vivo based on the physicochemical properties of Active Pharmaceutical Ingredients (API) and dosage for …
Modeling and simulation of drug dissolution and oral absorption has been increasingly used over the last decade to unde …
Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension.
Statelova M, Holm R, Fotaki N, Reppas C, Vertzoni M. Statelova M, et al. AAPS J. 2020 Nov 12;22(6):146. doi: 10.1208/s12248-020-00522-4. AAPS J. 2020. PMID: 33184711
The importance of physiologically based pharmacokinetic (PBPK) model refinement with data acquired in adults using a pediatric formulation under age-relevant dosing conditions in order to extrapolate drug exposure to infants was recently demonst …
The importance of physiologically based pharmacokinetic (PBPK) model refinement with data acquired in adults usi …
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