The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference
|
journal
|
January 2018 |
Physiological Parameters for Oral Delivery and in Vitro Testing
|
journal
|
October 2010 |
Application of the GastroDuo as an in Vitro Dissolution Tool To Simulate the Gastric Emptying of the Postprandial Stomach
|
journal
|
October 2019 |
Intragastric Volume Changes after Intake of a High-Caloric, High-Fat Standard Breakfast in Healthy Human Subjects Investigated by MRI
|
journal
|
April 2014 |
Food for thought: formulating away the food effect – a PEARRL review
|
journal
|
June 2018 |
The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group
|
journal
|
June 2019 |
Impact of regional differences along the gastrointestinal tract of healthy adults on oral drug absorption: An UNGAP review
|
journal
|
June 2019 |
In Vitro and In Vivo Test Methods for the Evaluation of Gastroretentive Dosage Forms
|
journal
|
August 2019 |
Intragastric pH and pressure profiles after intake of the high-caloric, high-fat meal as used for food effect studies
|
journal
|
December 2015 |
Simulating the Postprandial Stomach: Physiological Considerations for Dissolution and Release Testing
|
journal
|
April 2013 |
Introduction to the OrBiTo decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development
|
journal
|
September 2018 |
Investigating the Impact of Crohn’s Disease on the Bioaccessibility of a Lipid-Based Formulation with an In Vitro Dynamic Gastrointestinal Model
|
journal
|
March 2021 |
Integrated Upper Gastrointestinal Response to Food Intake
|
journal
|
August 2006 |
Disintegration of Solid Foods in Human Stomach
|
journal
|
June 2008 |
Designing a Dynamic Dissolution Method: A Review of Instrumental Options and Corresponding Physiology of Stomach and Small Intestine
|
journal
|
September 2013 |
Upper Gastrointestinal (GI) pH in Young, Healthy Men and Women
|
journal
|
January 1990 |
Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies
|
journal
|
January 2006 |
Development of a bio-relevant dissolution test device simulating mechanical aspects present in the fed stomach
|
journal
|
June 2014 |
Gastric Water Emptying under Fed State Clinical Trial Conditions Is as Fast as under Fasted Conditions
|
journal
|
October 2017 |
Application of the GastroDuo to study the interplay of drug release and gastric emptying in case of immediate release Aspirin formulations
|
journal
|
June 2020 |
Gastric emptying of multi-particulate dosage forms
|
journal
|
August 2010 |
A Human Gastric Simulator (HGS) to Study Food Digestion in Human Stomach
|
journal
|
November 2010 |
Current Methods for Predicting Human Food Effect
|
journal
|
May 2008 |
Influence of Food on the Bioavailability of Drugs
|
journal
|
January 1978 |
Review article: mechanisms of drug release from tablets and capsules. 2. Dissolution
|
journal
|
December 1989 |
Characterization of fasted human gastric fluid for relevant rheological parameters and gastric lipase activities
|
journal
|
November 2013 |
Clinical significance of gastric juice viscosity in peptic ulcer patients
|
journal
|
September 1988 |
Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes
|
journal
|
November 2019 |
Food Effects on Oral Drug Absorption: Application of Physiologically-Based Pharmacokinetic Modeling as a Predictive Tool
|
journal
|
July 2020 |
Effects of posture on the physiology of gastric emptying: A magnetic resonance imaging study
|
journal
|
January 2006 |
Effect of meal volume and calorie load on postprandial gastric function and emptying: studies under physiological conditions by combined fiber-optic pressure measurement and MRI
|
journal
|
November 2009 |
The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review
|
journal
|
September 2018 |
Resolving the physiological conditions in bioavailability and bioequivalence studies: Comparison of fasted and fed state
|
journal
|
November 2016 |
In vitro simulation of realistic gastric pressure profiles
|
journal
|
September 2017 |
Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update
|
journal
|
April 2008 |
Media to simulate the postprandial stomach I. Matching the physicochemical characteristics of standard breakfasts
|
journal
|
February 2010 |
The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug
|
journal
|
May 2010 |
Fed-state gastric media and drug analysis techniques: Current status and points to consider
|
journal
|
October 2016 |
Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches
|
journal
|
June 2020 |
Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study
|
journal
|
August 2017 |
Characterising the behaviour of poorly water soluble drugs in the intestine: application of biorelevant media for solubility, dissolution and transport studies
|
journal
|
July 2010 |
Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations
|
journal
|
August 2018 |
Absorption of minocycline hydrochloride and tetracycline hydrochloride
|
journal
|
February 1985 |
Effect of liquid volume and food intake on the absolute bioavailability of danazol, a poorly soluble drug
|
journal
|
March 2005 |
Solubilization and dissolution of insoluble weak acid, ketoprofen: Effects of pH combined with surfactant
|
journal
|
November 2006 |
Sustained-release from Layered Matrix System Comprising Chitosan and Xanthan Gum
|
journal
|
January 2007 |
Bottom-Up Physiologically Based Oral Absorption Modeling of Free Weak Base Drugs
|
journal
|
September 2020 |
Differences in Food Effects for 2 Weak Bases With Similar BCS Drug-Related Properties: What Is Happening in the Intestinal Lumen?
|
journal
|
September 2016 |
A new 5-aminosalicylic acid multi-unit dosage form for the therapy of ulcerative colitis
|
journal
|
May 2001 |
Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance Part 2: Dissolution of Montelukast Sodium and Mesalazine Formulations
|
journal
|
October 2020 |
Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance: Part 1—Effects on Solubility of Poorly Soluble Drugs
|
journal
|
June 2020 |
Intraluminal drug and formulation behavior and integration in in vitro permeability estimation: A case study with amprenavir
|
journal
|
February 2006 |
Postprandial Evolution in Composition and Characteristics of Human Duodenal Fluids in Different Nutritional States
|
journal
|
March 2009 |
Understanding the relationship between wettability and dissolution of solid dispersion
|
journal
|
April 2014 |
Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine—A Study with Felodipine as a Model Drug
|
journal
|
September 2015 |
Computational Fluid Dynamics Simulation of Hydrodynamics and Stresses in the PhEur/USP Disintegration Tester Under Fed and Fasted Fluid Characteristics
|
journal
|
September 2015 |
Theoretical Analysis of Drug Dissolution: I. Solubility and Intrinsic Dissolution Rate
|
journal
|
September 2016 |
Achieving Antral Grinding Forces in Biorelevant In Vitro Models: Comparing the USP Dissolution Apparatus II and the Dynamic Gastric Model with Human In Vivo Data
|
journal
|
May 2011 |
Irregular absorption profiles observed from diclofenac extended release tablets can be predicted using a dissolution test apparatus that mimics in vivo physical stresses
|
journal
|
October 2008 |
In Vitro Dissolution Testing of Gelatin Capsules with Applied Mechanical Compression—a Technical Note
|
journal
|
February 2016 |
Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release From Nifedipine Extended-Release Tablets*
|
journal
|
March 2019 |
Mechanistic understanding of time-dependent oral absorption based on gastric motor activity in humans
|
journal
|
September 2008 |
Does age affect gastric emptying time? A model‐based meta‐analysis of data from premature neonates through to adults
|
journal
|
February 2015 |
A Brief Review of the FDA Dissolution Methods Database
|
journal
|
January 2016 |
In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration
|
journal
|
March 2019 |
Comparison of In Vitro and In Vivo Results Using the GastroDuo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions
|
journal
|
December 2019 |
Combined Application of MRI and the Salivary Tracer Technique to Determine the in Vivo Disintegration Time of Immediate Release Formulation Administered to Healthy, Fasted Subjects
|
journal
|
March 2019 |
Low dose caffeine as a salivary tracer for the determination of gastric water emptying in fed and fasted state: A MRI validation study
|
journal
|
June 2018 |
Can dynamicin vitrodigestion systems mimic the physiological reality?
|
journal
|
January 2018 |
The Design, Operation, and Application of a Dynamic Gastric Model
|
journal
|
January 2012 |
Assessment of antral grinding of a model solid meal with echo-planar imaging
|
journal
|
May 2001 |
Predicting the human in vivo performance of different oral capsule shell types using a novel in vitro dynamic gastric model
|
journal
|
October 2011 |
A Formulation Case Study Comparing the Dynamic Gastric Model with Conventional Dissolution Methods
|
journal
|
January 2012 |
Evaluation of two dynamic in vitro models simulating fasted and fed state conditions in the upper gastrointestinal tract (TIM-1 and tiny-TIM) for investigating the bioaccessibility of pharmaceutical compounds from oral dosage forms
|
journal
|
February 2016 |
Influence of In Vitro Digestion on Composition, Bioaccessibility and Antioxidant Activity of Food Polyphenols—A Non-Systematic Review
|
journal
|
May 2020 |
A Multicompartmental Dynamic Computer-controlled Model Simulating the Stomach and Small Intestine
|
journal
|
March 1995 |
Simulation of Human Small Intestinal Digestion of Starch Using an In Vitro System Based on a Dialysis Membrane Process
|
journal
|
July 2020 |
Improved bioaccessibility of polymethoxyflavones loaded into high internal phase emulsions stabilized by biopolymeric complexes: A dynamic digestion study via TNO's gastrointestinal model
|
journal
|
June 2020 |
In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC
|
journal
|
January 2007 |
An Investigation into the Utility of a Multi-compartmental, Dynamic, System of the Upper Gastrointestinal Tract to Support Formulation Development and Establish Bioequivalence of Poorly Soluble Drugs
|
journal
|
February 2012 |
Development of an advanced in vitro model of the stomach and its evaluation versus human gastric physiology
|
journal
|
October 2016 |
On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: Case example sodium salt of A6197
|
journal
|
April 2020 |
Gastrointestinal and Systemic Disposition of Diclofenac under Fasted and Fed State Conditions Supporting the Evaluation of in Vitro Predictive Tools
|
journal
|
July 2017 |
Development of organogel-based emulsions to enhance the loading and bioaccessibility of 5-demethylnobiletin
|
journal
|
October 2021 |
Evaluation of the bioaccessibility of tetrahydrocurcumin-hyaluronic acid conjugate using in vitro and ex vivo models
|
journal
|
July 2021 |
Improving the bioaccessibility and bioavailability of carnosic acid using a lecithin-based nanoemulsion: complementary in vitro and in vivo studies
|
journal
|
January 2020 |
In vitro and in vivo correlation for lipid-based formulations: Current status and future perspectives
|
journal
|
August 2021 |
A level A in vitro/in vivo correlation in fasted and fed states using different methods: Applied to solid immediate release oral dosage form
|
journal
|
January 2006 |
Increased bioavailability of celecoxib under fed versus fasted conditions is determined by postprandial bile secretion as demonstrated in a dynamic gastrointestinal model
|
journal
|
February 2016 |
Relevance and challenges in modeling human gastric and small intestinal digestion
|
journal
|
November 2012 |
A standardised semi-dynamic in vitro digestion method suitable for food – an international consensus
|
journal
|
January 2020 |
Effect of gel structure on the gastric digestion of whey protein emulsion gels
|
journal
|
January 2014 |
Evaluation of a Three Compartment In Vitro Gastrointestinal Simulator Dissolution Apparatus to Predict In Vivo Dissolution
|
journal
|
November 2014 |
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report
|
journal
|
August 2018 |
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives
|
journal
|
December 2019 |
Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation
|
journal
|
January 2006 |
Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets
|
journal
|
January 2018 |
Development and Validation of In Vitro Discriminatory Dissolution Testing Method for Fast Dispersible Tablets of BCS Class II Drug
|
journal
|
February 2020 |
Machine learning methods for prediction of food effects on bioavailability: A comparison of support vector machines and artificial neural networks
|
journal
|
January 2022 |
Deep learning improves prediction of drug–drug and drug–food interactions
|
journal
|
April 2018 |
A Review of Current Methods for Food Effect Prediction During Drug Development
|
journal
|
September 2020 |
An Artificial Neural Network Approach to Predict the Effects of Formulation and Process Variables on Prednisone Release from a Multipartite System
|
journal
|
March 2019 |
Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data
|
journal
|
November 2012 |
Evaluation of the Use of Göttingen Minipigs to Predict Food Effects on the Oral Absorption of Drugs in Humans
|
journal
|
January 2015 |
Predicting Food Effects: Are We There Yet?
|
journal
|
January 2022 |
PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development
|
journal
|
January 2019 |
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
|
journal
|
October 2011 |
Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis
|
journal
|
July 2015 |
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification
|
journal
|
August 2015 |
Impact of Physiologically Based Pharmacokinetic Modeling and Simulation in Drug Development
|
journal
|
September 2013 |
Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies
|
journal
|
January 2019 |
Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status: Using PBPK to Predict Food Effect
|
journal
|
November 2017 |
Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound—The Venetoclax Story
|
journal
|
January 2018 |
Use of biorelevant dissolution and PBPK modeling to predict oral drug absorption
|
journal
|
August 2018 |
An integrated computational methodology with data-driven machine learning, molecular modeling and PBPK modeling to accelerate solid dispersion formulation design
|
journal
|
January 2021 |
Clinical Pharmacokinetics of Trospium Chloride
|
journal
|
January 2005 |
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models
|
journal
|
June 2021 |
Mechanistic investigation of food effect on disintegration and dissolution of BCS class III compound solid formulations: the importance of viscosity
|
journal
|
August 2012 |
Application of Physiologically‐Based Pharmacokinetic Modeling to Predict Gastric pH‐Dependent Drug–Drug Interactions for Weak Base Drugs
|
journal
|
July 2020 |
Effect of Low- and High-Fat Meals on the Pharmacokinetics of Venetoclax, a Selective First-in-Class BCL-2 Inhibitor
|
journal
|
October 2016 |
Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation
|
journal
|
November 2019 |
Physiologically Based Pharmacokinetic Modeling: Methodology, Applications, and Limitations with a Focus on Its Role in Pediatric Drug Development
|
journal
|
January 2011 |
Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms
|
journal
|
March 2013 |
Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective
|
journal
|
September 2020 |
PBPK Absorption Modeling: Establishing the In Vitro–In Vivo Link—Industry Perspective
|
journal
|
January 2019 |
Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
|
journal
|
February 2021 |
Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology
|
journal
|
January 2019 |