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A Knowledge Management Framework and Approach for Clinical Development

Therapeutic innovation & regulatory science, 2016-09, Vol.50 (5), p.536-545

2016

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Determination and differentiation of surface and bound water in drug substances by near infrared spectroscopy

Journal of pharmaceutical sciences, 2003-05, Vol.92 (5), p.1058-1065

2003

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Mechanistic study of enantiomeric recognition with native γ-cyclodextrin by capillary electrophoresis, reversed-phase liquid chromatography, nuclear magnetic resonance spectroscopy, electrospray mass spectrometry and circular dichroism techniques

Journal of Chromatography A, 2003-02, Vol.987 (1), p.409-420

2003

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A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins

Journal of pharmaceutical and biomedical analysis, 2002-01, Vol.27 (3), p.541-553

2002

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Characterization of a Thermally Induced Irreversible Conformational Transition of Amylose Tris(3,5-dimethylphenylcarbamate) Chiral Stationary Phase in Enantioseparation of Dihydropyrimidinone Acid by Quasi-Equilibrated Liquid Chromatography and Solid-State NMR

Analytical chemistry (Washington), 2003-11, Vol.75 (21), p.5877-5885

2003

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Evaluation of chiral purity for a substituted imidazole p38 MAP kinase inhibitor and its intermediates using a single chiral capillary electrophoresis method

Electrophoresis, 2004-08, Vol.25 (16), p.2860-2865

2004

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Chromatographic separation of 3,4-difluorophenylacetic acid and its positional isomers using five different techniques

Journal of Chromatography A, 2000-01, Vol.866 (2), p.281-292

2000

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Enantiomeric separation of a thiazolbenzenesulfonamide compound using packed-column subcritical fluid chromatography

Chirality (New York, N.Y.), 2002, Vol.14 (5), p.393-399

2002

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Practical aspects of fast HPLC separations for pharmaceutical process development using monolithic columns

Analytica chimica acta, 2004-10, Vol.523 (2), p.149-156

2004

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Use of a Quality-by-Design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols

Journal of pharmaceutical and biomedical analysis, 2009-12, Vol.50 (5), p.794-796

2009

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Unusual effect of column temperature on chromatographic enantioseparation of dihydropyrimidinone acid and methyl ester on amylose chiral stationary phase

Journal of Chromatography A, 2002-06, Vol.958 (1), p.69-77

2002

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THE SEPARATION OF POSITIONAL ISOMERS BY CAPILLARY ELECTROCHROMATOGRAPHY

Journal of liquid chromatography & related technologies, 2001-03, Vol.24 (6), p.755-771

2001

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Comparison study of Chiralpak AD-H with AD columns in chromatographic enantioseparation of dihydropyrimidinone acid and its methyl ester

Journal of Chromatography A, 2004-04, Vol.1034 (1), p.117-123

2004

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Chiral capillary electrophoretic analysis of the enantiomeric purity of a pharmaceutical compound using sulfated β-cyclodextrin

Journal of Chromatography A, 2000-04, Vol.875 (1), p.389-401

2000

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Mechanistic study of the enantiomeric recognition of a basic compound with negatively charged single-isomer γ-cyclodextrin derivatives using capillary electrophoresis, nuclear magnetic resonance spectroscopy, and infrared spectroscopy

Electrophoresis, 2003-08, Vol.24 (15), p.2448-2455

2003

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A convenient, general synthesis of .alpha.-trichloromethyl carbinols

Journal of organic chemistry, 1987-03, Vol.52 (5), p.944-945

1987

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Examination of rofecoxib solution decomposition under alkaline and photolytic stress conditions

Journal of pharmaceutical and biomedical analysis, 2002-06, Vol.28 (6), p.1101-1113

2002

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Electrophoretic chiral separation of pharmaceutical compounds with multiple stereogenic centers in charged cyclodextrin media

Journal of separation science, 2001-05, Vol.24 (5), p.378-384

2001

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Enantiomeric separation of enzymatic hydrolysis products of dihydropyrimidinone methyl ester with cationic cyclodextrin by capillary electrophoresis

Journal of Chromatography A, 2000-03, Vol.872 (1), p.279-288

2000

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Simultaneous enantioseparation of a basic drug compound and its acidic intermediate by capillary electrophoresis

Journal of separation science, 2002-11, Vol.25 (15-17), p.1183-1189

2002

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Simultaneous enantioseparation of a basic drug compound and its acidic intermediate by capillary electrophoresis: Electromigration Methods

Journal of separation science, 2002, Vol.25 (15-17), p.1183-1189

2002

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A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins: The impact of enantioseparation techniques on the development and use of chiral drugs

Journal of pharmaceutical and biomedical analysis, 2002, Vol.27 (3-4), p.541-553

2002

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Evaluation of the origins of the selectivity of polymers imprinted with a HIV protease inhibitor using infrared spectroscopy and high performance liquid chromatography

Enantiomer, 2002-03, Vol.7 (2-3), p.139

2002

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Development of an Indirect Reverse Phase Method for the Quality Assessment of an Acyl Halide

Journal of liquid chromatography & related technologies, 1998-02, Vol.21 (4), p.575-589

1998

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On-line monitoring of the distillates of a solvent switch process by near-infrared spectroscopy

Process control and quality, 1999-01, Vol.11 (4), p.277-287

1999

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A Knowledge Management Framework and Approach for Clinical Development

Determination and differentiation of surface and bound water in drug substances by near infrared spectroscopy

Mechanistic study of enantiomeric recognition with native γ-cyclodextrin by capillary electrophoresis, reversed-phase liquid chromatography, nuclear magnetic resonance spectroscopy, electrospray mass spectrometry and circular dichroism techniques

A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins

Characterization of a Thermally Induced Irreversible Conformational Transition of Amylose Tris(3,5-dimethylphenylcarbamate) Chiral Stationary Phase in Enantioseparation of Dihydropyrimidinone Acid by Quasi-Equilibrated Liquid Chromatography and Solid-State NMR

Evaluation of chiral purity for a substituted imidazole p38 MAP kinase inhibitor and its intermediates using a single chiral capillary electrophoresis method

Chromatographic separation of 3,4-difluorophenylacetic acid and its positional isomers using five different techniques

Enantiomeric separation of a thiazolbenzenesulfonamide compound using packed-column subcritical fluid chromatography

Practical aspects of fast HPLC separations for pharmaceutical process development using monolithic columns

Use of a Quality-by-Design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols

Unusual effect of column temperature on chromatographic enantioseparation of dihydropyrimidinone acid and methyl ester on amylose chiral stationary phase

THE SEPARATION OF POSITIONAL ISOMERS BY CAPILLARY ELECTROCHROMATOGRAPHY

Comparison study of Chiralpak AD-H with AD columns in chromatographic enantioseparation of dihydropyrimidinone acid and its methyl ester

Chiral capillary electrophoretic analysis of the enantiomeric purity of a pharmaceutical compound using sulfated β-cyclodextrin

Mechanistic study of the enantiomeric recognition of a basic compound with negatively charged single-isomer γ-cyclodextrin derivatives using capillary electrophoresis, nuclear magnetic resonance spectroscopy, and infrared spectroscopy

A convenient, general synthesis of .alpha.-trichloromethyl carbinols

Examination of rofecoxib solution decomposition under alkaline and photolytic stress conditions

Electrophoretic chiral separation of pharmaceutical compounds with multiple stereogenic centers in charged cyclodextrin media

Enantiomeric separation of enzymatic hydrolysis products of dihydropyrimidinone methyl ester with cationic cyclodextrin by capillary electrophoresis

Simultaneous enantioseparation of a basic drug compound and its acidic intermediate by capillary electrophoresis

Simultaneous enantioseparation of a basic drug compound and its acidic intermediate by capillary electrophoresis: Electromigration Methods

A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins: The impact of enantioseparation techniques on the development and use of chiral drugs

Evaluation of the origins of the selectivity of polymers imprinted with a HIV protease inhibitor using infrared spectroscopy and high performance liquid chromatography

Development of an Indirect Reverse Phase Method for the Quality Assessment of an Acyl Halide

On-line monitoring of the distillates of a solvent switch process by near-infrared spectroscopy

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