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The Role of Physiologically Based Oral Absorption Modelling in Formulation Development Under a Quality by Design Paradigm

Journal of pharmaceutical sciences, 2017-04, Vol.106 (4), p.944-949

Kesisoglou, Filippos

2017

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Physiologically Based Oral Absorption Modelling to Study Gut-Level Drug Interactions

Journal of pharmaceutical sciences, 2018-01, Vol.107 (1), p.18-23

2018

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Effect of Amorphous Nanoparticle Size on Bioavailability of Anacetrapib in Dogs

Journal of pharmaceutical sciences, 2019-09, Vol.108 (9), p.2917-2925

2019

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

Journal of pharmaceutical sciences, 2021-12, Vol.110 (12), p.3896-3906

2021

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Characteristics of the Human Upper Gastrointestinal Contents in the Fasted State Under Hypo- and A-chlorhydric Gastric Conditions Under Conditions of Typical Drug – Drug Interaction Studies

Pharmaceutical research, 2016-06, Vol.33 (6), p.1399-1412

2016

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The Introduction of a New Flexible In Vivo Predictive Dissolution Apparatus, GIS-Alpha (GIS-α), to Study Dissolution Profiles of BCS Class IIb Drugs, Dipyridamole and Ketoconazole

Journal of pharmaceutical sciences, 2020-11, Vol.109 (11), p.3471-3479

2020

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Amorphous Solid Dispersions or Prodrugs: Complementary Strategies to Increase Drug Absorption

Journal of pharmaceutical sciences, 2016-09, Vol.105 (9), p.2498-2508

2016

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

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.592-602

2019

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

Journal of pharmaceutical sciences, 2016-02, Vol.105 (2), p.722-728

2016

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Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Journal of pharmaceutical sciences, 2018-01, Vol.107 (1), p.34-41

2018

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Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls

Journal of pharmaceutical sciences, 2015-09, Vol.104 (9), p.2913-2922

2015

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

Journal of pharmaceutical sciences, 2020-03, Vol.109 (3), p.1380-1394

2020

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Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept

Pharmaceutical research, 2023-02, Vol.40 (2), p.419-429

2023

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An Extrusion Spheronization Approach to Enable a High Drug Load Formulation of a Poorly Soluble Drug with a Low Melting Surfactant

Journal of pharmaceutical sciences, 2015-11, Vol.104 (11), p.3752-3759

2015

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Enabling an HCV Treatment Revolution and the Frontiers of Solid Solution Formulation

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.50-57

2019

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Two-Stage Single-Compartment Models to Evaluate Dissolution in the Lower Intestine

Journal of pharmaceutical sciences, 2015-09, Vol.104 (9), p.2986-2997

2015

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Inhaled Cisplatin for NSCLC: Facts and Results

International journal of molecular sciences, 2019-04, Vol.20 (8), p.2005

2019

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Possibilities and Limiting Factors for the Use of Dissolution as a Quality Control Tool to Detect Presence of Crystallinity for Amorphous Solid Dispersions: An Experimental and Modeling Investigation

Journal of pharmaceutical sciences, 2019-09, Vol.108 (9), p.3054-3062

2019

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

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.574-583

2019

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Genes' Interactions: A Major Contributor to the Malignant Transformation of Endometriosis

International journal of molecular sciences, 2019-04, Vol.20 (8), p.1842

2019

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Molecular Mechanism of P53 Peptide Permeation through Lipid Membranes from Solid-State NMR Spectroscopy and Molecular Dynamics Simulations

Journal of the American Chemical Society, 2024-08, Vol.146 (33), p.23075-23091

2024

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

Journal of pharmaceutical sciences, 2021-02, Vol.110 (2), p.584-593

2021

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In Vitro Biopredictive Methods: A Workshop Summary Report

Journal of pharmaceutical sciences, 2021-02, Vol.110 (2), p.567-583

2021

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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Journal of pharmaceutical sciences, 2016-11, Vol.105 (11), p.3243-3255

2016

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Suitability of a Minipig Model in Assessing Clinical Bioperformance of Matrix and Multiparticulate Extended-Release Formulations for a BCS Class III Drug Development Candidate

Journal of pharmaceutical sciences, 2014-02, Vol.103 (2), p.636-642

2014

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The Role of Physiologically Based Oral Absorption Modelling in Formulation Development Under a Quality by Design Paradigm

Physiologically Based Oral Absorption Modelling to Study Gut-Level Drug Interactions

Effect of Amorphous Nanoparticle Size on Bioavailability of Anacetrapib in Dogs

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

Characteristics of the Human Upper Gastrointestinal Contents in the Fasted State Under Hypo- and A-chlorhydric Gastric Conditions Under Conditions of Typical Drug – Drug Interaction Studies

The Introduction of a New Flexible In Vivo Predictive Dissolution Apparatus, GIS-Alpha (GIS-α), to Study Dissolution Profiles of BCS Class IIb Drugs, Dipyridamole and Ketoconazole

Amorphous Solid Dispersions or Prodrugs: Complementary Strategies to Increase Drug Absorption

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

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

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls

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

Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept

An Extrusion Spheronization Approach to Enable a High Drug Load Formulation of a Poorly Soluble Drug with a Low Melting Surfactant

Enabling an HCV Treatment Revolution and the Frontiers of Solid Solution Formulation

Two-Stage Single-Compartment Models to Evaluate Dissolution in the Lower Intestine

Inhaled Cisplatin for NSCLC: Facts and Results

Possibilities and Limiting Factors for the Use of Dissolution as a Quality Control Tool to Detect Presence of Crystallinity for Amorphous Solid Dispersions: An Experimental and Modeling Investigation

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

Genes' Interactions: A Major Contributor to the Malignant Transformation of Endometriosis

Molecular Mechanism of P53 Peptide Permeation through Lipid Membranes from Solid-State NMR Spectroscopy and Molecular Dynamics Simulations

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

In Vitro Biopredictive Methods: A Workshop Summary Report

Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Suitability of a Minipig Model in Assessing Clinical Bioperformance of Matrix and Multiparticulate Extended-Release Formulations for a BCS Class III Drug Development Candidate

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