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Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals

Journal of pharmaceutical sciences, 2017-11, Vol.106 (11), p.3199-3206

2017

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Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice

Journal of pharmaceutical sciences, 2017-11, Vol.106 (11), p.3199-3206

2017

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Effect of drug load and plate coating on the particle size distribution of a commercial albuterol metered dose inhaler (MDI) determined using the Andersen and Marple-Miller Cascade impactors

Pharmaceutical research, 1997-10, Vol.14 (10), p.1437-1443

1997

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Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach

AAPS PharmSciTech, 2004-04, Vol.5 (1), p.E22-158

2004

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Algorithms for Validating Chiral Properties of Insulins

Analytical chemistry (Washington), 1999-08, Vol.71 (16), p.3341-3346

1999

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Understanding QbD challenges: to understand the challenges and opportunities associated with implementing quality by design (QbD), FDA contracted an independent consultant to evaluate current industry adoption of QbD. This article summarises those findings and proposes actions FDA can take to encourage full-scale QbD implementation

Pharmaceutical technology Europe, 2011-09, Vol.23 (9), p.10

2011

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In vitro study of nicotine release from smokeless tobacco

Journal of AOAC International, 1998-05, Vol.81 (3), p.540-543

1998

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Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach

AAPS PharmSciTech, 2004-01, Vol.5 (1), p.151-158

2004

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An inverse reactivity-selectivity relationship. Kinetic nitrogen isotope effects on methyl transfer to pyridines

Journal of the American Chemical Society, 1982-10, Vol.104 (21), p.5823-5824

1982

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Effect of formulation factors on the observed bounce in cascade impactors used to measure the spray particle size of metered dose inhalers

International journal of pharmaceutics, 1998-10, Vol.173 (1), p.93-102

1998

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An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture, 2017, p.9-24

2017

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Isotope effects on isotope effects: equilibrium nitrogen isotope effects on the basicity of pyridine in protium and deuterium oxides

Journal of physical chemistry (1952), 1989, Vol.93 (2), p.937-942

1989

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Kinetic nitrogen isotope effects on methyl transfer to amines

Journal of physical chemistry (1952), 1986-10, Vol.90 (21), p.5357-5360

1986

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Loading effect on particle size measurements by inertial sampling of albuterol metered dose inhalers

Pharmaceutical research, 1995-11, Vol.12 (11), p.1677-1681

1995

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Equilibrium nitrogen isotope effects on the basicity of amines

Journal of physical chemistry (1952), 1986-10, Vol.90 (21), p.5360-5363

1986

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High Performance Liquid Chromatographic Assay of Erythromycin Salts and Esters in Bulk and Pharmaceutical Dosage Forms

Journal of liquid chromatography & related technologies, 1998-04, Vol.21 (8), p.1147-1160

1998

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High Performance Liquid Chromatographic Analysis of Erythromycin

Journal of liquid chromatography & related technologies, 1996-08, Vol.19 (14), p.2329-2348

1996

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High Performance Liquid Chromatographic Analysis of Erythromycin and Related Impurities in Pharmaceutical Formulations

Journal of liquid chromatography & related technologies, 1997-02, Vol.20 (4), p.553-565

1997

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Understanding challenges to quality by design

Pharmaceutical Technology, 2011-09, Vol.35 (9), p.60

2011

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Understanding challenges to quality by design

Pharmaceutical Technology, 2012-06, Vol.36, p.207

2012

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Modal Properties of an Index Guiding Nematic Liquid Crystal Based Photonic Crystal Fiber

Journal of lightwave technology, 2009-11, Vol.27 (21), p.4754-4762

2009

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Characterization of Currently Marketed Heparin Products: Reversed-Phase Ion-Pairing Liquid Chromatography Mass Spectrometry of Heparin Digests

Analytical chemistry (Washington), 2010-12, Vol.82 (23), p.9865-9870

2010

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Identification of heparin samples that contain impurities or contaminants by chemometric pattern recognition analysis of proton NMR spectral data

Analytical and bioanalytical chemistry, 2011-08, Vol.401 (3), p.939-955

2011

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Determination of galactosamine impurities in heparin samples by multivariate regression analysis of their (1)H NMR spectra

Analytical and bioanalytical chemistry, 2011-01, Vol.399 (2), p.635-649

2011

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Combining (1)H NMR spectroscopy and chemometrics to identify heparin samples that may possess dermatan sulfate (DS) impurities or oversulfated chondroitin sulfate (OSCS) contaminants

Journal of pharmaceutical and biomedical analysis, 2011-04, Vol.54 (5), p.1020-1029

2011

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Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice

Effect of drug load and plate coating on the particle size distribution of a commercial albuterol metered dose inhaler (MDI) determined using the Andersen and Marple-Miller Cascade impactors

Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach

Algorithms for Validating Chiral Properties of Insulins

In vitro study of nicotine release from smokeless tobacco

Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach

An inverse reactivity-selectivity relationship. Kinetic nitrogen isotope effects on methyl transfer to pyridines

Effect of formulation factors on the observed bounce in cascade impactors used to measure the spray particle size of metered dose inhalers

An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture

Isotope effects on isotope effects: equilibrium nitrogen isotope effects on the basicity of pyridine in protium and deuterium oxides

Kinetic nitrogen isotope effects on methyl transfer to amines

Loading effect on particle size measurements by inertial sampling of albuterol metered dose inhalers

Equilibrium nitrogen isotope effects on the basicity of amines

High Performance Liquid Chromatographic Assay of Erythromycin Salts and Esters in Bulk and Pharmaceutical Dosage Forms

High Performance Liquid Chromatographic Analysis of Erythromycin

High Performance Liquid Chromatographic Analysis of Erythromycin and Related Impurities in Pharmaceutical Formulations

Understanding challenges to quality by design

Understanding challenges to quality by design

Modal Properties of an Index Guiding Nematic Liquid Crystal Based Photonic Crystal Fiber

Characterization of Currently Marketed Heparin Products: Reversed-Phase Ion-Pairing Liquid Chromatography Mass Spectrometry of Heparin Digests

Identification of heparin samples that contain impurities or contaminants by chemometric pattern recognition analysis of proton NMR spectral data

Determination of galactosamine impurities in heparin samples by multivariate regression analysis of their (1)H NMR spectra

Combining (1)H NMR spectroscopy and chemometrics to identify heparin samples that may possess dermatan sulfate (DS) impurities or oversulfated chondroitin sulfate (OSCS) contaminants

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