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

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

Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

(2021) Mosab Arafat et al.   Pharmaceuticals

Physiologically Based Absorption Modelling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Entrectinib

(2020) Neil Parrott et al.   AAPS Journal

Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

(2020) Lei Miao et al.   AAPS Journal

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

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

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations

(2020) Maxime Le Merdy et al.   PHARMACEUTICAL RESEARCH

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

(2020) Amitava Mitra et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2019) Jereb Rebeka et al.   AAPS PHARMSCITECH

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

(2019) Tycho Heimbach et al.   AAPS Journal

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

(2019) Maxime Le Merdy et al.   AAPS Journal

Ocular biopharmaceutics: impact of modeling and simulation on topical ophthalmic formulation development

(2019) Hovhannes J. Gukasyan et al.   DRUG DISCOVERY TODAY

Evaluating the Bioequivalence of Metronidazole Tablets and Analyzing the Effect of in Vitro Dissolution on in Vivo Absorption Based on PBPK Modeling

(2019) Shuqi Zhang et al.   DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Integrating drug- and formulation-related properties with gastrointestinal tract variability using a product-specific particle size approach: case example ibuprofen

(2019) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Justification of Biowaiver and Dissolution Rate Specifications for Piroxicam Immediate Release Products Based on Physiologically Based Pharmacokinetic Modeling: An In-Depth Analysis

(2019) Xiaoting Li et al.   MOLECULAR PHARMACEUTICS

In vitro–In vivo Relationship and Bioequivalence Prediction for Modified-Release Capsules Based on a PBPK Absorption Model

(2019) Rebeka Jereb et al.   AAPS PHARMSCITECH

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

(2019) Ioannis Loisios-Konstantinidis et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

(2018) Andreas Abend et al.   AAPS Journal

Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound—The Venetoclax Story

(2018) Arian Emami Riedmaier et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2018) Christophe Tistaert et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Long Acting Injectables – Current Perspective and Future Promises

(2018) komal Chaudhary et al.   CRITICAL REVIEWS IN THERAPEUTIC DRUG CARRIER SYSTEMS

Model-based drug development in pulmonary delivery: Pharmacokinetic analysis of novel drug candidates for treatment of Pseudomonas aeruginosa lung infection

(2018) Tomás Sou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically based absorption modeling to predict bioequivalence of controlled release and immediate release oral products

(2018) Amitava Mitra et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

The Irrelevance of In Vitro Dissolution in Setting Product Specifications for Drugs Like Dextromethorphan That are Subject to Lysosomal Trapping

(2018) Michael B. Bolger et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanistic investigation of the negative food effect of modified release zolpidem

(2017) Cord J. Andreas et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Development of Guanfacine Extended-Release Dosing Strategies in Children and Adolescents with ADHD Using a Physiologically Based Pharmacokinetic Model to Predict Drug–Drug Interactions with Moderate CYP3A4 Inhibitors or Inducers

(2017) Aiqun Li et al.   PEDIATRIC DRUGS

In vitro–in vivo and pharmacokinetic evaluation of solid lipid nanoparticles of furosemide using Gastroplus™

(2017) Hasan Ali et al.   RSC Advances

Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency

(2016) E Luzon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Exploring the Feasibility of Biowaiver Extension of BCS Class III Drugs with Site-Specific Absorption Using Gastrointestinal Simulation Technology

(2016) Le Sun et al.   EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

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

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

PBPK modeling and simulation in drug research and development

(2016) Xiaomei Zhuang et al.   Acta Pharmaceutica Sinica B

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

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA

(2015) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Prediction of in-vivo pharmacokinetic profile for immediate and modified release oral dosage forms of furosemide using an in-vitro-in-silico-in-vivo approach

(2015) Keiichi Otsuka et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

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

(2015) David J. Good et al.   MOLECULAR PHARMACEUTICS

Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

(2014) Amitava Mitra et al.   AAPS PHARMSCITECH

Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration

(2014) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Biorelevant media for transport experiments in the Caco-2 model to evaluate drug absorption in the fasted and the fed state and their usefulness

(2013) C. Markopoulos et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Dose Selection Based on Physiologically Based Pharmacokinetic (PBPK) Approaches

(2012) Hannah M. Jones et al.   AAPS Journal

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

(2012) R Leong et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Application of PBPK modelling in drug discovery and development at Pfizer

(2011) Hannah M Jones et al.   XENOBIOTICA

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Mechanism-based prediction of particle size-dependent dissolution and absorption: Cilostazol pharmacokinetics in dogs

(2010) Stefan Willmann et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

The Biowaiver Extension for BCS Class III Drugs: The Effect of Dissolution Rate on the Bioequivalence of BCS Class III Immediate-Release Drugs Predicted by Computer Simulation

(2010) Yasuhiro Tsume et al.   MOLECULAR PHARMACEUTICS

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

(2009) Viera Lukacova et al.   AAPS Journal

Computer simulations using GastroPlus™ to justify a biowaiver for etoricoxib solid oral drug products

(2008) Arthur Okumu et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation

(2008) Ivan Kovačević et al.   MOLECULAR PHARMACEUTICS

Delivering drugs by the transdermal route: review and comment

(2008) T. Tanner et al.   SKIN RESEARCH AND TECHNOLOGY