Journal Articles Prediction of intestinal absorption: comparative assessment of GastroPlus and IDEA. Journal Articles Solidified SNEDDS of loratadine: Formulation using hydrophilic and hydrophobic grades of Aerosil®, pharmacokinetic evaluations and in vivo-in silico predictions using GastroPlus Journal Articles Physiologically-Based Pharmacokinetic Modeling in Lead Optimization I: Evaluation and Adaptation of GastroPlus to Predict Bioavailability of Medchem Series. Journal Articles Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products. Journal Articles Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug Journal Articles In silico modeling of gastrointestinal drug absorption: predictive performance of three physiologically based absorption models Journal Articles Preclinical pharmacokinetic studies of 3-deazaneplanocin A, a potent epigenetic anticancer agent, and its human pharmacokinetic prediction using GastroPlus™ Journal Articles Pharmacokinetics and Pharmacodynamics of Phase II Drug Metabolizing / Antioxidant Enzymes Gene Response by Anti-cancer Agent Sulforaphane in Rat Lymphocytes Journal Articles Role of physiological intestinal water in oral absorption. Journal Articles In Silico Modeling for the Nonlinear Absorption Kinetics of UK-343,664: A P-gp and CYP3A4 Substrate Journal Articles Predicting Pharmacokinetic Profiles Using In Silico Derived Parameters Journal Articles Evaluation of the GastroPlus™ Advanced Compartmental and Transit (ACAT) Model in Early Discovery Journal Articles Practical Anticipation of Human Efficacious Doses and Pharmacokinetics Using In Vitro and Preclinical In Vivo Data. Journal Articles Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing Journal Articles A pH-Dilution Method for Estimation of Biorelevant Drug Solubility along the Gastrointestinal Tract: Application to Physiologically Based Pharmacokinetic Modeling. Journal Articles The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation. Journal Articles A framework for 2-stage global sensitivity analysis of GastroPlus™ compartmental models Journal Articles The Application of Physiologically Based Pharmacokinetic Modelling to Understanding the Clinical Pharmacokinetics of UK-369,003. Journal Articles Neuroprotective Potential of Peroxisome Proliferator Activated Receptor-a Agonist in Cognitive Impairment in Parkinson’s Disease: Behavioral, Biochemical, and PBPK Profile Journal Articles Justification of drug product dissolution rate and drug substance particle size specifications based on absorption PBPK modelling for lesinurad immediate release tablets Journal Articles Prediction of the pharmacokinetics and tissue distribution of levofloxacin in humans based on an extrapolated PBPK model Journal Articles Prediction of Pharmacokinetics and Penetration of Moxifloxacin in Human with Intra-Abdominal Infection Based on Extrapolated PBPK Model Journal Articles Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics. Journal Articles The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools Journal Articles Nilotinib preclinical pharmacokinetics and practical application toward clinical projections of oral absorption and systemic availability Journal Articles Preclinical Assessment of the Absorption and Disposition of the Phosphatidylinositol 3-Kinase/Mammalian Target of Rapamycin Inhibitor GDC-0980 and Prediction of Its Pharmacokinetics and Efficacy in Human Journal Articles Parameters for pyrethroid insecticide QSAR and PBPK/PD models for human risk assessment Journal Articles Developability assessment of clinical drug products with maximum absorbable doses Journal Articles Parameters for pyrethroid insecticide QSAR and PBPK/PD models for human risk assessment Journal Articles Investigating Oral Absorption of Carbamazepine in Pediatric Populations. Journal Articles Model-Based Bioequivalence assessment of a commercial Azithromycin Capsule against Pfizer Zithromax® Tablet marketed in Jamaica Journal Articles In vitro to in vivo extrapolation and physiologically based modeling of cytochrome P450 mediated metabolism in beagle dog gut wall and liver Journal Articles Evaluation of a Three Compartment In Vitro Gastrointestinal Simulator Dissolution Apparatus to Predict In Vivo Dissolution Journal Articles In Vitro Characterization of Axitinib Interactions with Human Efflux and Hepatic Uptake Transporters. Implications for Disposition and Drug Interactions Journal Articles Influence of different proton pump inhibitors on the pharmacokinetics of voriconazole Journal Articles Clinical Pharmacokinetics of Buffered Propranolol Sublingual Tablet (Promptol™)—Application of a New “Physiologically Based” Model to Assess Absorption and Disposition Journal Articles Application of Physiologically Based Absorption Modeling to Formulation Development of a Low Solubility, Low Permeability Weak Base: Mechanistic Investigation of Food Effect Journal Articles A PPAR-ß/d Agonist is Neuroprotective and Decreases Cognitive Impairment in a Rodent Model of Parkinson’s Disease Journal Articles The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC Journal Articles Developing a mechanistic absorption model to predict the pharmacokinetics of immediate-release weak base drugs with a long Tmax by incorporating lysosomal trapping. Journal Articles Utility of Physiologically Based Modeling and Preclinical In Vitro/In Vivo Data to Mitigate Positive Food Effect in a BCS Class 2 Compound Journal Articles In vitro dissolution methodology, mini-Gastrointestinal Simulator (mGIS), predicts better in vivo dissolution of a weak base drug, dasatinib Journal Articles Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data. Journal Articles Establishment of physiologically based pharmacokinetic model of atorvastatin Journal Articles Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs. Journal Articles Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man. Journal Articles Physicochemical properties of the nucleoside prodrug R1626 leading to high oral bioavailability. Journal Articles Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate Journal Articles Applications of physiologically based absorption models in drug discovery and development. Journal Articles Simulations of the nonlinear dose dependence for substrates of influx and efflux transporters in the human intestine. Journal Articles In Vitro, in Silico, and in Vivo Assessments of Intestinal Precipitation and Its Impact on Bioavailability of a BCS Class 2 Basic Compound. Journal Articles Predicting pharmacokinetics of drugs using physiologically based modeling – application to food effects. Journal Articles Predicting pharmacokinetics of anti-cancer drug, famitinib in human using physiologically based pharmacokinetic model Journal Articles Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug. Journal Articles Regional intestinal absorption and biliary excretion of fluvastatin in the rat: possible involvement of mrp2. Journal Articles In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation. Journal Articles Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Journal Articles Mitigation of Adverse Clinical Events of a Narrow Target Therapeutic Index Compound through Modified Release Formulation Design: An In Vitro, In Vivo, In Silico, and Clinical Pharmacokinetic Analysis Journal Articles Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation Journal Articles Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI project Journal Articles Prediction of pharmacokinetics and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach: A case study of caffeine and ciprofloxacin Journal Articles Exploring and validating physicochemical properties of mangiferin through GastroPlus® software Journal Articles Physiologically Based Pharmacokinetic (PBPK) Modeling of Pharmaceutical Nanoparticles Journal Articles Extension of the dissolution-precipitation model for kinetic elucidation of solvent-mediated polymorphic transformations Journal Articles A Staged Approach to Pharmaceutical Dissolution Testing Journal Articles In vitro dissolution models for the prediction of in vivo performance of an oral mesoporous silica formulation Journal Articles Progress in Prediction and Interpretation of Clinically Relevant Metabolic Drug-Drug Interactions: a Minireview Illustrating Recent Developments and Current Opportunities Journal Articles Investigating the effect of autoinduction in cynomolgus monkeys of a novel anticancer MDM2 antagonist, idasanutlin, and relevance to humans Journal Articles In Vitro Evaluation of Absorption Characteristics of Peramivir for Oral Delivery Journal Articles Preclinical pharmacokinetics of TPN729MA, a novel PDE5 inhibitor, and prediction of its human pharmacokinetics using a PBPK model Journal Articles Food effect: The combined effect of media pH and viscosity on the gastrointestinal absorption of ciprofloxacin tablet Journal Articles Mechanistic understanding of the effect of renal impairment on metformin oral absorption using computer simulations Journal Articles Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect Journal Articles Report from EMA Workshop on Qualification and Reporting of Physiologically‐based Pharmacokinetic (PBPK) Modelling and Simulation Journal Articles Forecasting oral absorption across biopharmaceutics classification system classes with physiologically based pharmacokinetic models Journal Articles In vitro dissolution models for the prediction of in vivo performance of an oral mesoporous silica formulation Journal Articles Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: in vitro, in vivo and in silico assessments Journal Articles In vivo in silico pharmacokinetic simulation studies of carvedilol-loaded nanocapsules using GastroPlus™ Journal Articles In vitro–in vivo–in silico simulation studies of anti-tubercular drugs doped with a self nanoemulsifying drug delivery system Journal Articles Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib Journal Articles Clinical Micro-Dose Studies to Explore the Human Pharmacokinetics of Four Selective Inhibitors of Human Nav1.7 Voltage-Dependent Sodium Channels Journal Articles Application of in vitro transmucosal permeability, dose number, and maximum absorbable dose for biopharmaceutics assessment during early drug development for intraoral delivery Journal Articles Estimating Margin of Exposure to Thyroid Peroxidase Inhibitors Using High-throughput In Vitro Data, High-throughput Exposure Modeling, and Physiologically-Based Pharmacokinetic / Pharmacodynamic Modeling Journal Articles Simulation of the pharmacokinetics of bisoprolol in healthy adults and patients with impaired renal function using whole-body physiologically based pharmacokinetic modeling Journal Articles Development of a unified dissolution and precipitation model and its use for the prediction of oral drug absorption Journal Articles Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib. Journal Articles Disease specific modeling: simulation of the pharmacokinetics of meloxicam and ibuprofen in disease state vs. healthy conditions Journal Articles In vitro-in vivo correlations: general concepts, methodologies and regulatory applications Journal Articles Absorption, distribution, metabolism, excretion, and kinetics of 2,3,3,3-tetrafluoro-2- (heptafluoropropoxy) proprionic acid ammonium salt following a single dose in rat, mouse, and cynomolgus monkey Journal Articles Mechanistic Investigation of Negative Food Effect for BCS Class III Compounds in Solid Dosage Forms Journal Articles Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality Journal Articles Toward Biopredictive Dissolution for Enteric Coated Dosage Forms Journal Articles Methodology of oral formulation selection in the pharmaceutical industry Journal Articles IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results Journal Articles Mechanistic prediction of food effects for Compound A tablet using PBPK model Journal Articles Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Journal Articles The impact of supersaturation level for oral absorption of BCS class IIb drugs, dipyridamole and ketoconazole, using in vivo predictive dissolution system: Gastrointestinal Simulator (GIS) Journal Articles Combining an In Vitro Kinetic Model with a Physiologically-Based Pharmacokinetic Model to Assess the Potential In Vivo Fate of Polyvinyl Pyrrolidone-Vinyl Acetate Copolymers. Journal Articles Computer Simulation in Pharmacokinetic and Pharmacodynamic Studies. Journal Articles Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach. Journal Articles Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs. Journal Articles Industry’s View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization. Journal Articles In vitro to in vivo extrapolation for high throughput prioritization and decision making. Journal Articles Preparation and Evaluation of Progesterone Nanocrystals to Decrease Muscle Irritation and Improve Bioavailability. Journal Articles Physiologically-Based Pharmacokinetic Modeling in Lead Optimization II: “Rational Bioavailability Design” by Global Sensitivity Analysis to Identify Properties Affecting Bioavailability. Journal Articles Physiologically Based Oral Absorption Modelling to Study Gut-Level Drug Interactions Journal Articles An in vitro – in silico approach for the formulation and characterization of ranitidine gastroretentive delivery systems Journal Articles Assessing the risk of alcohol-induced dose dumping from sustained-release oral dosage forms: in vitro-in silico approach. Journal Articles In vitro/in silico approach in the development of simvastatin-loaded self-microemulsifying drug delivery systems. Journal Articles Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours Journal Articles The Combination of GIS and Biphasic to Better Predict In Vivo Dissolution of BCS Class IIb Drugs, Ketoconazole and Raloxifene. Journal Articles Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations. Journal Articles Absolute Oral Bioavailability of Creatine Monohydrate in Rats: Debunking a Myth. Journal Articles Exploring gastric emptying rate in minipigs: Effect of food type and pre-dosing of metoclopramide. Journal Articles Pharmacokinetics and interspecies scaling of a novel, orally-bioavailable anti-cancer drug, SHetA2. Journal Articles In Vitro Dissolution Methodology And Estimated Consequences Of Biowaiver Extension For Immediate Release Solid Oral Dosage Forms With Metformin Hydrochloride Journal Articles Critical Evaluation of 2-Ethylhexyl Acrylate Dermal Carcinogenicity Studies Using Contemporary Criteria. Journal Articles State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development Journal Articles A Preclinical Bioavailability Strategy for Decisions on Clinical Drug Formulation Development: an In Depth Analysis Journal Articles Whole-body physiology-based pharmacokinetics of caspofungin for general patients, intensive care unit patients and hepatic insufficiency patients. Journal Articles Use of Biorelevant Dissolution and PBPK Modeling to Predict Oral Drug Absorption. Journal Articles Physiologically Based Absorption Modeling of Salts of Weak Bases Based on Data in Hypochlorhydric and Achlorhydric Biorelevant Media. Journal Articles Amino acid conjugated chitosan nanoparticles for the brain targeting of a model dipeptidyl peptidase-4 inhibitor. Journal Articles Glycyrrhizin has a high likelihood to be a victim of drug-drug interactions mediated by hepatic OATP1B1/1B3. Journal Articles Software based approaches for drug designing and development: A systematic review on commonly used software and its applications. Journal Articles Quantitative Systems Pharmacology Approach for Risk Assessment on Drug-Induced Proarrhythmic Effects with Physiologically Based Pharmacokinetic Model. Journal Articles The impact of reduced gastric acid secretion on dissolution of salts of weak bases in the fasted upper gastrointestinal lumen: Data in biorelevant media and in human aspirates. Journal Articles Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound with Region-Dependent Absorption Journal Articles Exploring Canine – Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs Journal Articles Mechanistic investigation of the negative food effect of modified release zolpidem Journal Articles Food Effect on Oral Bioavailability: Old and New Questions Journal Articles Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations Journal Articles Integrating in vitro, modeling, and in vivo approaches to investigate warfarin bioequivalence Journal Articles Development and qualification of physiologically based pharmacokinetic models for drugs with atypical distribution behavior: A desipramine case study. Journal Articles Prediction of Losartan Active Carboxylic Acid Metabolite Exposure Following Losartan Administration Using Static and Physiologically-Based Pharmacokinetic Models. Journal Articles Studies on Core-Shell Nanocapsules of Felodipine: In Vitro-In Vivo Evaluations. Journal Articles Lipophilic salts of poorly soluble compounds to enable high-dose lipidic SEDDS formulations in drug discovery. Journal Articles A strategy for early risk predictions of clinical drug-drug interactions involving the GastroPlusTM DDI module for time-dependent CYP inhibitors. Journal Articles Comparison of oral absorption properties among different bisphosphonates by using a newly developed physiologically based pharmacokinetic model. Journal Articles A cross-species translational pharmacokinetic-pharmacodynamic evaluation of core bodytemperature reduction by the TRPM8 blocker PF-05105679. Journal Articles Food effects in paediatric medicines development for products Co-administered with food Journal Articles Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation Journal Articles Applications of Mechanistic Modeling and Simulations in Compound and Dosage Forms Selections Journal Articles Bio–relevant characterisation of lipidic formulations and prediction of in vivo exposure Journal Articles Development of long-circulating docetaxel loaded poly (3-hydroxybutyrate-co-3-hydroxyvalerate) nanoparticles: optimization, pharmacokinetic, cytotoxicity and in vivo assessments Journal Articles Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors Journal Articles Calcium Phosphate Particles as Pulmonary Delivery System for Interferon-α in Mice Journal Articles Oral product input to the GI tract: GIS an oral product performance technology Journal Articles In Silico Absorption Analysis of Valacyclovir in Wildtype and Pept1 Knockout Mice Following Oral Dose Escalation Journal Articles Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications. Journal Articles Biorelevant Dissolution Models for a Weak Base To Facilitate Formulation Development and Overcome Reduced Bioavailability Caused by Hypochlordyria or Achlorhydria. Journal Articles Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics. Journal Articles Coupled in silico platform: Computational fluid dynamics (CFD) and physiologically-based pharmacokinetic (PBPK) modelling Journal Articles The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations Journal Articles Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans Journal Articles Prediction of pH dependent absorption using in vitro, in silico, and in vivo rat models: Early liability assessment during lead optimization Journal Articles Quantitative aspects of drug permeation across in vitro and in vivo barriers Journal Articles Circadian Variations in Exsorptive Transport: In Situ Intestinal Perfusion Data and In Vivo Relevance Journal Articles Selection of oral bioavailability enhancing formulations during drug discovery Journal Articles Comparison of in vitro–in vivo release of Risperdal® Consta® microspheres Journal Articles Developing In Vitro–In Vivo Correlation of Risperidone Immediate Release Tablet Journal Articles Application of PBPK modeling to predict human intestinal metabolism of CYP3A substrates – An evaluation and case study using GastroPlus™ Journal Articles The Use of Modeling Tools to Drive Efficient Oral Product Design Journal Articles Novel physiologically based pharmacokinetic modeling of patupilone for human pharmacokinetic predictions Journal Articles Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data Journal Articles Nilotinib preclinical pharmacokinetics and practical application toward clinical projections of oral absorption and systemic availability Journal Articles Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis: part I. oral absorption of magnesium Journal Articles Predicting feasibility and characterizing performance of extended-release formulations using physiologically based pharmacokinetic modeling Journal Articles Use of In Vitro-In Vivo Correlation to Predict the Pharmacokinetics of Several Products Containing a BCS Class 1 Drug in Extended Release Matrices Journal Articles In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen Journal Articles Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development. Journal Articles Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling Journal Articles Application of Target-Mediated Drug Disposition Model to Small Molecule Heat Shock Protein 90 Inhibitors Journal Articles Single-Dose Safety, Tolerability, and Pharmacokinetics of the Antibiotic GSK1322322, a Novel Peptide Deformylase Inhibitor Journal Articles Effects of novel cathepsin K inhibitor ONO-5334 on bone resorption markers: a study of four sustained release formulations with different pharmacokinetic patterns Journal Articles PBPK models for the prediction of in vivo performance of oral dosage forms Journal Articles Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling Journal Articles Assessing the Risk of pH-Dependent Absorption for New Molecular Entities: A Novel in Vitro Dissolution Test, Physicochemical Analysis, and Risk Assessment Strategy Journal Articles Use of Preclinical Dog Studies and Absorption Modeling to Facilitate Late Stage Formulation Bridging for a BCS II Drug Candidate Journal Articles Incorporation of Physiologically Based Pharmacokinetic Modeling in the Evaluation of Solubility Requirements for the Salt Selection Process: A Case Study Using Phenytoin Journal Articles In Vitro-In Vivo Correlation of Efavirenz Tablets Using GastroPlus® Journal Articles A Simplified PBPK Modeling Approach for Prediction of Pharmacokinetics of Four Primarily Renally Excreted and CYP3A Metabolized Compounds During Pregnancy Journal Articles Pharmacokinetics of dietary cancer chemopreventive compound dibenzoylmethane in rats and the impact of nanoemulsion and genetic knockout of Nrf2 on its disposition Journal Articles Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling. Journal Articles Profiling Biopharmaceutical Deciding Properties of Absorption of Lansoprazole Enteric-Coated Tablets Using Gastrointestinal Simulation Technology Journal Articles Understanding the effect of API properties on bioavailability through absorption modeling. Journal Articles Composite solubility versus pH profile and its role in intestinal absorption prediction. Journal Articles Simulation of absorption, metabolism, and bioavailability. Journal Articles Development of clinical dosage forms for a poorly water soluble drug I: application of polyethylene glycol-polysorbate 80 solid dispersion carrier system. Journal Articles An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery. Journal Articles Application of full physiological models for pharmaceutical drug candidate selection and extrapolation of pharmacokinetics to man. Journal Articles Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Journal Articles A strategy for preclinical formulation development using GastroPlus™ as pharmacokinetic simulation tool and a statistical screening design applied to a dog study. Journal Articles In silico modeling of nonlinear drug absorption for the P-gp substrate talinolol and of consequences for the resulting pharmacodynamic effect. Journal Articles The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools. Journal Articles Dynamic dissolution testing to establish In Vitro / In Vivo Correlations for montelukast sodium, a poorly soluble drug. Journal Articles Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds. Journal Articles A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe. Journal Articles Effect of gastric pH on the pharmacokinetics of a BCS Class II compound in dogs: Utilization of an artificial stomach and duodenum dissolution model and GastroPlus™ simulations to predict absorption. Journal Articles Physicochemical characterization of five glyburide powders: a BCS based approach to predict oral absorption. Journal Articles Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data. Journal Articles The use of gastrointestinal intubation studies for controlled release development. Journal Articles Modelling and PBPK simulation in drug discovery. Journal Articles An investigation into the importance of “Very Rapid Dissolution” criteria for drug bioequivalence demonstration using gastrointestinal simulation technology. Journal Articles Prediction of Oral Pharmacokinetics of cMet Kinase Inhibitors in Humans: Physiologically Based Pharmacokinetic Model versus Traditional One Compartment Model. Journal Articles Black tea improves attention and self-reported alertness. Journal Articles Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants. Journal Articles The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation. Journal Articles Application of PBPK modelling in drug discovery and development at Pfizer. Journal Articles Pre-clinical and clinical pharmacokinetics of PF-02413873, a non-steroidal progesterone receptor antagonist. Journal Articles Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible. Journal Articles Physiologically based pharmacokinetic and pharmacodynamic modeling of an antagonist (SM-406/AT-406) of multiple inhibitor of apoptosis proteins (IAPs) in a mouse xenograft model of human breast cancer Journal Articles Amorphous solid dispersions and nano-crystal technologies for poorly water-soluble drug delivery Journal Articles Development of Physiologically Based Pharmacokinetic / Pharmacodynamic Model for Indomethacin Disposition in Pregnancy Journal Articles Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation Journal Articles Physiologically based pharmacokinetic modelling in drug discovery and development: A pharmaceutical industry perspective Journal Articles The potency–insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors Journal Articles Utilizing Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility Journal Articles Interspecies prediction of oral pharmacokinetics of different formulations from dogs to human: physiologically based pharmacokinetic modelling combined with biorelevant dissolution Journal Articles Comparison of biorelevant simulated media mimicking the intestinal environment to assess the solubility profiles of poorly soluble drugs Journal Articles Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem Journal Articles Role of Self-Association and Supersaturation in Oral Absorption of a Poorly Soluble Weakly Basic Drug Journal Articles Prospective Predictions of Human Pharmacokinetics for Eighteen Compounds Journal Articles Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models Journal Articles Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs Journal Articles Predicting drug absorption by computational methods. Journal Articles Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems Journal Articles Novel Orally Swallowable IntelliCap(®) Device to Quantify Regional Drug Absorption in Human GI Tract Using Diltiazem as Model Drug Journal Articles Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm Journal Articles Application of physiologically based pharmacokinetic modeling in the prediction of pharmacokinetics of bicyclol controlled-release formulation in human Journal Articles Acute toxicity prediction in multiple species by leveraging mechanistic ToxCast mitochondrial inhibition data and simulation of oral bioavailability Journal Articles Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling Journal Articles A long-duration dihydroorotate dehydrogenase inhibitor (DSM265) for prevention and treatment of malaria Journal Articles pH-Dependent Solubility and Dissolution Behavior of Carvedilol-Case Example of a Weakly Basic BCS Class II Drug Journal Articles PEGylated y-tocotrienol isomer of vitamin E: Synthesis, characterization, in vitro cytotoxicity, and oral bioavailability Journal Articles In vitro-in vivo correlation of parenteral risperidone polymeric microspheres Journal Articles Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A systematic review of published models, applications and model verification Journal Articles Effects of Cytochrome P450 3A4 Inhibitors – Ketoconazole and Erythromycin – on Bitopertin Pharmacokinetics and Comparison with Physiologically Based Modelling Predictions Journal Articles A canine biorelevant dissolution method for predicting in vivo performance of orally administered sustained release matrix tablets Journal Articles Physicochemical and Pharmacokinetic Characterization of Amorphous Solid Dispersion of Meloxicam with Enhanced Dissolution Property and Storage Stability Journal Articles Predicting drug-drug interactions involving multiple mechanisms using physiologically based pharmacokinetic modeling: A case study with ruxolitinib Journal Articles Dissolution testing combined with computer simulation technology to evaluate the bioequivalence of domestic amoxicillin capsule Journal Articles Compartmental absorption modeling and site of absorption studies to determine feasibility of an extended-release formulation of an HIV-1 attachment inhibitor phosphate ester prodrug Journal Articles Pharmacokinetics of Paracetamol in Göttingen Minipigs: In Vivo Studies and Modeling to Elucidate Physiological Determinants of Absorption Journal Articles Physiologically Based Pharmacokinetic Modelling to Predict Single- and Multiple-Dose Human Pharmacokinetics of Bitopertin Journal Articles A Case Study of In Silico Modelling of Ciprofloxacin Hydrochloride / Metallic Compound Interactions Journal Articles Viscosity-mediated negative food effect on oral absorption of poorly-permeable drugs with an absorption window in the proximal intestine: In vitro experimental simulation and computational verification Journal Articles Physiologically based pharmacokinetic modeling framework for quantitative prediction of an herb-drug interaction Journal Articles Characterization of preclinical in vitro and in vivo ADME properties and prediction of human PK using a physiologically-based pharmacokinetic model for YQA-14, a new dopamine D3 receptor antagonist candidate for treatment of drug addiction Journal Articles Implementing Toxicity Testing in the 21st Century (TT21C): Making safety decisions using toxicity pathways, and progress in a prototype risk assessment Journal Articles Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates Journal Articles Physiologically based pharmacokinetic modeling of CYP3A4 induction by rifampicin in human: influence of time between substrate and inducer administration Journal Articles From Bench to Humans: Formulation Development of a Poorly Water Soluble Drug to Mitigate Food Effect Journal Articles Modelling the Absorption of Metformin with Patients Post Gastric Bypass Surgery Journal Articles Testicular distribution and toxicity of a novel LTA4H inhibitor in rats Journal Articles Translational PK/PD modeling for cardiovascular safety assessment of drug candidates: Methods and examples in drug development Journal Articles Biopharmaceutical profiling of new antitumor pyrazole derivatives Journal Articles In vitro – in silico – in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study Journal Articles Simulation of the In Vivo Exposure to Ibuprofen Based on In Vitro Dissolution Profiles from Solid Dosage Forms Journal Articles Enhanced Solubility and Oral Bioavailability of y-Tocotrienol Using a Self-Emulsifying Drug Delivery System (SEDDS) Journal Articles Physiologically Based Absorption Modelling to Predict the Impact of Drug Properties on Pharmacokinetics of Bitopertin Journal Articles PEGylated cyclodextrins as novel siRNA nanosystems: Correlations between polyethylene glycol length and nanoparticle stability Journal Articles Improvement of trospium-specific absorption models for fasted and fed states in humans Journal Articles Intestinal transport of TRH analogs through PepT1: the role of in silico and in vitro modeling Journal Articles Development of nanocrystal formulation of meloxicam with improved dissolution and pharmacokinetic behaviors Journal Articles Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets Journal Articles Preparation and Evaluation of High Dispersion Stable Nanocrystal Formulation of Poorly Water-Soluble Compounds by Using Povacoat Journal Articles Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling Journal Articles The potency-insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors Journal Articles Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model.