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Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

The AAPS journal, 2015-09, Vol.17 (5), p.1224-1236

2015

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Understanding the Effect of API Properties on Bioavailability Through Absorption Modeling

The AAPS journal, 2008-12, Vol.10 (4), p.516-525

2008

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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

European journal of pharmaceutics and biopharmaceutics, 2017-06, Vol.115, p.94-101

2017

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Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations

Molecular pharmaceutics, 2016-09, Vol.13 (9), p.3206-3215

2016

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

The AAPS journal, 2018-05, Vol.20 (3), p.60-60, Article 60

2018

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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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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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Using Absorption Simulation and Gastric pH Modulated Dog Model for Formulation Development To Overcome Achlorhydria Effect

Molecular pharmaceutics, 2011-12, Vol.8 (6), p.2216-2223

2011

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Evolution of Choice of Solubility and Dissolution Media After Two Decades of Biopharmaceutical Classification System

The AAPS journal, 2017-07, Vol.19 (4), p.989-1001

2017

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

The AAPS journal, 2019-02, Vol.21 (2), p.29-29, Article 29

2019

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Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis

The AAPS journal, 2023-06, Vol.25 (4), p.60-60, Article 60

2023

Volltextzugriff (PDF)

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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Prediction of food effects on the absorption of celecoxib based on biorelevant dissolution testing coupled with physiologically based pharmacokinetic modeling

European journal of pharmaceutics and biopharmaceutics, 2009-09, Vol.73 (1), p.107-114

2009

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Preclinical Dose Number and Its Application in Understanding Drug Absorption Risk and Formulation Design for Preclinical Species

Molecular pharmaceutics, 2015-04, Vol.12 (4), p.1031-1039

2015

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Comparing Dog and Human Intestinal Fluids: Implications on Solubility and Biopharmaceutical Risk Assessment

AAPS PharmSciTech, 2017-05, Vol.18 (4), p.1408-1416

2017

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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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Effect of Added Alkalizer and Surfactant on Dissolution and Absorption of the Potassium Salt of a Weakly Basic Poorly Water-Soluble Drug

Journal of pharmaceutical sciences, 2014-06, Vol.103 (6), p.1811-1818

2014

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Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

The AAPS journal, 2010-09, Vol.12 (3), p.465-472

2010

Volltextzugriff (PDF)

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Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

Understanding the Effect of API Properties on Bioavailability Through Absorption Modeling

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

Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations

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

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

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

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

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

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

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

Using Absorption Simulation and Gastric pH Modulated Dog Model for Formulation Development To Overcome Achlorhydria Effect

Evolution of Choice of Solubility and Dissolution Media After Two Decades of Biopharmaceutical Classification System

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

Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis

In Vitro Biopredictive Methods: A Workshop Summary Report

Prediction of food effects on the absorption of celecoxib based on biorelevant dissolution testing coupled with physiologically based pharmacokinetic modeling

Preclinical Dose Number and Its Application in Understanding Drug Absorption Risk and Formulation Design for Preclinical Species

Comparing Dog and Human Intestinal Fluids: Implications on Solubility and Biopharmaceutical Risk Assessment

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

Effect of Added Alkalizer and Surfactant on Dissolution and Absorption of the Potassium Salt of a Weakly Basic Poorly Water-Soluble Drug

Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

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