Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development

An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow

(2022) Aktham Aburub et al.   AAPS Journal

Applications of PBPK/PBBM modeling in generic product development: An industry perspective

(2022) Yuvaneshwari K et al.   JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY

Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective

(2022) Wen Lin et al.   PHARMACEUTICAL RESEARCH

Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs

(2022) Di Wu et al.   PHARMACEUTICAL RESEARCH

Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach

(2021) Xavier J. H. Pepin et al.   AAPS Journal

Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability

(2021) Rahul Kumar et al.   Journal of Pharmaceutical Innovation

Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

(2021) Fang Wu et al.   AAPS Journal

Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models

(2021) Christian Wagner et al.   AAPS Journal

Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

(2021) Eleftheria Tsakalozou et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review

(2021) Zahari Vinarov et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

(2021) Tycho Heimbach et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanistic PBPK Modelling to Predict the Advantage of the Salt Form of a Drug When Dosed with Acid Reducing Agents

(2021) Siri Kalyan Chirumamilla et al.   Pharmaceutics

Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption

(2021) Marc Laisney et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Artemisinin Cocrystals for Bioavailability Enhancement. Part 2: In Vivo Bioavailability and Physiologically Based Pharmacokinetic Modeling

(2021) Manreet Kaur et al.   MOLECULAR PHARMACEUTICS

Drug-drug interactions between palbociclib and proton pump inhibitors may significantly affect clinical outcome of metastatic breast cancer patients

(2021) M. Del Re et al.   ESMO Open

Physiologically based pharmacokinetic model outputs depend on dissolution data and their input: Case examples glibenclamide and dipyridamole

(2020) Lukas Klumpp et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches

(2020) Takafumi Kato et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective

(2020) Arian Emami Riedmaier et al.   AAPS Journal

Biliary Excretion–Mediated Food Effects and Prediction

(2020) Jingcheng Xiao et al.   AAPS Journal

Physiologically Based Pharmacokinetic Modeling Approach to Identify the Drug–Drug Interaction Mechanism of Nifedipine and a Proton Pump Inhibitor, Omeprazole

(2020) Maxime Le Merdy et al.   EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.

(2020) Neil Parrott et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets

(2020) Rafael L.M. Paraiso et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Modelling for First-In-Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies

(2019) Neil A. Miller et al.   CLINICAL PHARMACOKINETICS

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

(2019) Tycho Heimbach et al.   AAPS Journal

Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

(2019) Sheila Annie Peters et al.   CLINICAL PHARMACOKINETICS

Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes

(2019) Domagoj Segregur et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanistic Deconvolution of Oral Absorption Model with Dynamic Gastrointestinal Fluid to Predict Regional Rate and Extent of GI Drug Dissolution

(2019) Alex Yu et al.   AAPS Journal

Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs using Physiologically based Biopharmaceutics Modeling: Industry Case Studies

(2019) Amitava Mitra et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

(2019) Mark McAllister et al.   Pharmaceutics

Biopharmaceutic IVIVE – Mechanistic Modelling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation into PBPK Models

(2018) Shriram M. Pathak et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Integration of Precipitation Kinetics From an In Vitro, Multicompartment Transfer System and Mechanistic Oral Absorption Modeling for Pharmacokinetic Prediction of Weakly Basic Drugs

(2018) Sanjaykumar Patel et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Bioequivalence Comparison of Pediatric Dasatinib Formulations and Elucidation of Absorption Mechanisms Through Integrated PBPK Modeling

(2018) Shruthi Vaidhyanathan et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions

(2017) Mark J. Koenigsknecht et al.   MOLECULAR PHARMACEUTICS

In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole

(2017) Bart Hens et al.   MOLECULAR PHARMACEUTICS

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

(2016) Sandra Suarez-Sharp et al.   AAPS Journal

Prediction of the precipitation profiles of weak base drugs in the small intestine using a simplified transfer (“dumping”) model coupled with in silico modeling and simulation approach

(2016) Atsushi Kambayashi et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound With Region-Dependent Absorption

(2016) Filippos Kesisoglou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies

(2016) Filippos Kesisoglou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

(2016) Xavier J. H. Pepin et al.   MOLECULAR PHARMACEUTICS

Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

(2016) Alex Yu et al.   MOLECULAR PHARMACEUTICS

Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate

(2015) Filippos Kesisoglou et al.   AAPS Journal

Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling

(2015) Xuan Ding et al.   AAPS Journal

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

(2015) HM Jones et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

In vitro dissolution methodology, mini-Gastrointestinal Simulator (mGIS), predicts better in vivo dissolution of a weak base drug, dasatinib

(2015) Yasuhiro Tsume et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Managing potential drug-drug interactions between gastric acid-reducing agents and antiretroviral therapy: experience from a large HIV-positive cohort

(2015) JM Lewis et al.   INTERNATIONAL JOURNAL OF STD & AIDS

Prospective Predictions of Human Pharmacokinetics for Eighteen Compounds

(2015) Tao Zhang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

(2014) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Incorporation of Physiologically Based Pharmacokinetic Modeling in the Evaluation of Solubility Requirements for the Salt Selection Process: A Case Study Using Phenytoin

(2013) Po-Chang Chiang et al.   AAPS Journal

Prevalence of Acid-Reducing Agents (ARA) in Cancer Populations and ARA Drug–Drug Interaction Potential for Molecular Targeted Agents in Clinical Development

(2013) Gillian S. Smelick et al.   MOLECULAR PHARMACEUTICS

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

(2012) Paul A. Dickinson et al.   AAPS Journal

Modification of physicochemical characteristics of active pharmaceutical ingredients and application of supersaturatable dosage forms for improving bioavailability of poorly absorbed drugs

(2012) Kohsaku Kawakami   ADVANCED DRUG DELIVERY REVIEWS

Drug Absorption Interactions Between Oral Targeted Anticancer Agents and PPIs: Is pH-Dependent Solubility the Achilles Heel of Targeted Therapy?

(2012) N R Budha et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Predicting the oral absorption of a poorly soluble, poorly permeable weak base using biorelevant dissolution and transfer model tests coupled with a physiologically based pharmacokinetic model

(2012) Christian Wagner et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

(2011) Xinyuan Zhang et al.   AAPS Journal

Diverse approaches for the enhancement of oral drug bioavailability

(2011) Pius Fasinu et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Application of PBPK modelling in drug discovery and development at Pfizer

(2011) Hannah M Jones et al.   XENOBIOTICA

Mechanistic Approaches to Predicting Oral Drug Absorption

(2009) Weili Huang et al.   AAPS Journal

Population-Based Mechanistic Prediction of Oral Drug Absorption

(2009) Masoud Jamei et al.   AAPS Journal

Understanding the Effect of API Properties on Bioavailability Through Absorption Modeling

(2008) Filippos Kesisoglou et al.   AAPS Journal

Current Methods for Predicting Human Food Effect

(2008) Kimberley A. Lentz   AAPS Journal

Rate-Limiting Steps of Oral Absorption for Poorly Water-Soluble Drugs in Dogs; Prediction from a Miniscale Dissolution Test and a Physiologically-Based Computer Simulation

(2008) Ryusuke Takano et al.   PHARMACEUTICAL RESEARCH