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Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

CPT: pharmacometrics and systems pharmacology, 2017-08, Vol.6 (8), p.492-495

2017

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Dissolution testing as a prognostic tool for oral drug absorption : Immediate release dosage forms

Pharmaceutical research, 1998, Vol.15 (1), p.11-22

1998

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Biopharmaceutics classification system: The scientific basis for biowaiver extensions

Pharmaceutical research, 2002-07, Vol.19 (7), p.921-925

2002

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HT29-MTX/Caco-2 Cocultures as an in Vitro Model for the Intestinal Epithelium: In Vitro–in Vivo Correlation with Permeability Data from Rats and Humans

Journal of pharmaceutical sciences, 1996-10, Vol.85 (10), p.1070-1076

1996

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Mechanistic analysis and experimental verification of bicarbonate-controlled enteric coat dissolution: Potential in vivo implications

European journal of pharmaceutics and biopharmaceutics, 2019-06, Vol.139, p.47-58

2019

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Lessons Learned from Marketed and Investigational Prodrugs

Journal of medicinal chemistry, 2004-05, Vol.47 (10), p.2393-2404

2004

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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

Molecular pharmaceutics, 2010-08, Vol.7 (4), p.1235-1243

2010

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A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals

Journal of clinical pharmacology, 2002-06, Vol.42 (6), p.620-643

2002

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Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

Clinical pharmacology and therapeutics, 2011-09, Vol.90 (3), p.467-470

2011

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Polymer degradation and in vitro release of a model protein from poly( d, l-lactide- co-glycolide) nano- and microparticles

Journal of controlled release, 2003-09, Vol.92 (1), p.173-187

2003

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The BCS, BDDCS, and Regulatory Guidances

Pharmaceutical research, 2011-07, Vol.28 (7), p.1774-1778

2011

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Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards

European Journal of Pharmaceutics and Biopharmaceutics, 2000-07, Vol.50 (1), p.3-12

2000

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Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Journal of pharmaceutical sciences, 2009-04, Vol.98 (4), p.1206-1219

2009

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Novel method to assess gastric emptying in humans: the Pellet Gastric Emptying Test

European journal of pharmaceutical sciences, 2001-12, Vol.14 (4), p.347-353

2001

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Dissolution Media for In Vitro Testing of Water-Insoluble Drugs: Effect of Surfactant Purity and Electrolyte on In Vitro Dissolution of Carbamazepine in Aqueous Solutions of Sodium Lauryl Sulfate

Journal of pharmaceutical sciences, 1997-03, Vol.86 (3), p.384-388

1997

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A compartmental absorption and transit model for estimating oral drug absorption

International journal of pharmaceutics, 1999-09, Vol.186 (2), p.119-125

1999

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Comparison of human duodenum and Caco-2 gene expression profiles for 12,000 gene sequences tags and correlation with permeability of 26 drugs

Pharmaceutical research, 2002-10, Vol.19 (10), p.1400-1416

2002

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The mechanism of uptake of biodegradable microparticles in Caco-2 cells is size dependent

Pharmaceutical research, 1997-11, Vol.14 (11), p.1568-1573

1997

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Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs

International journal of pharmaceutics, 2004-02, Vol.270 (1), p.221-227

2004

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Gastrointestinal uptake of biodegradable microparticles : Effect of particle size

Pharmaceutical research, 1996-12, Vol.13 (12), p.1838-1845

1996

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Caco‐2 versus Caco‐2/HT29‐MTX Co‐cultured Cell Lines: Permeabilities Via Diffusion, Inside‐ and Outside‐Directed Carrier‐Mediated Transport

Journal of pharmaceutical sciences, 2000-01, Vol.89 (1), p.63-75

2000

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Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

Journal of pharmaceutical sciences, 2004-08, Vol.93 (8), p.1945-1956

2004

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A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability

Pharmaceutical research, 1995-03, Vol.12 (3), p.413-420

1995

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Surfactant-mediated dissolution: Contributions of solubility enhancement and relatively low micelle diffusivity

Journal of pharmaceutical sciences, 2004-08, Vol.93 (8), p.2064-2075

2004

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Amino Acid Ester Prodrugs of the Antiviral Agent 2-Bromo-5,6-dichloro-1-(β-d-ribofuranosyl)benzimidazole as Potential Substrates of hPEPT1 Transporter

Journal of medicinal chemistry, 2005-02, Vol.48 (4), p.1274-1277

2005

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Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

Dissolution testing as a prognostic tool for oral drug absorption : Immediate release dosage forms

Biopharmaceutics classification system: The scientific basis for biowaiver extensions

HT29-MTX/Caco-2 Cocultures as an in Vitro Model for the Intestinal Epithelium: In Vitro–in Vivo Correlation with Permeability Data from Rats and Humans

Mechanistic analysis and experimental verification of bicarbonate-controlled enteric coat dissolution: Potential in vivo implications

Lessons Learned from Marketed and Investigational Prodrugs

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

A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals

Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

Polymer degradation and in vitro release of a model protein from poly( d, l-lactide- co-glycolide) nano- and microparticles

The BCS, BDDCS, and Regulatory Guidances

Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Novel method to assess gastric emptying in humans: the Pellet Gastric Emptying Test

Dissolution Media for In Vitro Testing of Water-Insoluble Drugs: Effect of Surfactant Purity and Electrolyte on In Vitro Dissolution of Carbamazepine in Aqueous Solutions of Sodium Lauryl Sulfate

A compartmental absorption and transit model for estimating oral drug absorption

Comparison of human duodenum and Caco-2 gene expression profiles for 12,000 gene sequences tags and correlation with permeability of 26 drugs

The mechanism of uptake of biodegradable microparticles in Caco-2 cells is size dependent

Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs

Gastrointestinal uptake of biodegradable microparticles : Effect of particle size

Caco‐2 versus Caco‐2/HT29‐MTX Co‐cultured Cell Lines: Permeabilities Via Diffusion, Inside‐ and Outside‐Directed Carrier‐Mediated Transport

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability

Surfactant-mediated dissolution: Contributions of solubility enhancement and relatively low micelle diffusivity

Amino Acid Ester Prodrugs of the Antiviral Agent 2-Bromo-5,6-dichloro-1-(β-d-ribofuranosyl)benzimidazole as Potential Substrates of hPEPT1 Transporter

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