Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies

scientific article published on 12 June 2018

Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1016/J.XPHS.2018.05.024
P698PubMed publication ID29906472

P2093author name stringFilippos Kesisoglou
Tycho Heimbach
Binfeng Xia
Neil Parrott
Christophe Tistaert
Tanay S Samant
P2860cites workA theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailabilityQ28293773
Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compoundQ30662113
Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implicationsQ33605319
In vitro-in vivo correlations for lipophilic, poorly water-soluble drugsQ34061188
Physiologically based absorption modelling to predict the impact of drug properties on pharmacokinetics of bitopertinQ34099804
BDDCS applied to over 900 drugsQ34206152
Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification systemQ34403502
The pharmacokinetics and bioavailability of a tracer dose of [3H]-mebendazole in man.Q34622486
The Role of CDK4/6 Inhibition in Breast CancerQ35586728
Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorptionQ37058658
A review of drug solubility in human intestinal fluids: implications for the prediction of oral absorption.Q38133189
PBPK models for the prediction of in vivo performance of oral dosage formsQ38141441
Direct In Vivo Human Intestinal Permeability (Peff ) Determined with Different Clinical Perfusion and Intubation MethodsQ38269764
Incorporation of the Time-Varying Postprandial Increase in Splanchnic Blood Flow into a PBPK Model to Predict the Effect of Food on the Pharmacokinetics of Orally Administered High-Extraction Drugs.Q38773640
Profiling and trend analysis of food effects on oral drug absorption considering micelle interaction and solubilization by bile micellesQ39612238
Predicting intestinal precipitation--a case example for a basic BCS class II drugQ39846636
Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.Q40606545
Characterization of Human Duodenal Fluids in Fasted and Fed State Conditions.Q40675687
Gastrointestinal behavior of nano- and microsized fenofibrate: In vivo evaluation in man and in vitro simulation by assessment of the permeation potentialQ40907845
Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and developmentQ41768726
Role of physiological intestinal water in oral absorptionQ43117344
Prediction of food effect by bile micelles on oral drug absorption considering free fraction in intestinal fluidQ43121950
The pharmacokinetics and bioavailability of mebendazole in man: a pilot study using [3H]-mebendazoleQ43261606
Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug AdministrationQ45201599
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical EvaluationsQ46297172
Physiologically based pharmacokinetic modelling to predict single- and multiple-dose human pharmacokinetics of bitopertinQ46379587
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: comparative assessment of prediction methods of human volume of distributionQ46873334
Physiologically Based Pharmacokinetic Model Predictions of Panobinostat (LBH589) as a Victim and Perpetrator of Drug-Drug InteractionsQ47982766
Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.Q48358292
Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current StatusQ49716638
The impact of gastric pH, volume, and emptying on the food effect of ziprasidone oral absorption.Q50786823
Upper gastrointestinal (GI) pH in young, healthy men and women.Q51615125
Oral absorption of poorly water-soluble drugs: computer simulation of fraction absorbed in humans from a miniscale dissolution test.Q52668360
Development and validation of a preclinical food effect modelQ79318173
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearanceQ84032967
P433issue1
P921main subjectpharmacokineticsQ323936
P304page(s)592-602
P577publication date2018-06-12
P1433published inJournal of Pharmaceutical SciencesQ3186933
P1476titleFood Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies
P478volume108

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cites work (P2860)
Q89500030A multiscale absorption and transit model for oral drug delivery: Formulation and applications during fasting conditions
Q94538992Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
Q102206232In vitro and in vivo evaluation of 3D printed capsules with pressure triggered release mechanism for oral peptide delivery
Q91510523Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies
Q93006074Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

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