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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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The US regulatory and pharmacopeia response to the global heparin contamination crisis

Nature biotechnology, 2016-06, Vol.34 (6), p.625-630

2016

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Regulatory and Quality Considerations for Continuous Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Journal of pharmaceutical sciences, 2015-03, Vol.104 (3), p.803-812

2015

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Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen

Journal of pharmaceutical sciences, 2019-11, Vol.108 (11), p.3521-3523

2019

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Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Journal of pharmaceutical sciences, 2015-03, Vol.104 (3), p.832-839

2015

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Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

Journal of pharmaceutical sciences, 2015-03, Vol.104 (3), p.803

2015

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Emerging Applications and Regulatory Strategies for Advanced Medicines Manufacturing – Towards the Development of a Platform Approach

Journal of pharmaceutical sciences, 2024-07, Vol.113 (7), p.1701-1710

2024

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Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events

Nature biotechnology, 2008-06, Vol.26 (6), p.669-675

2008

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Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System

The New England journal of medicine, 2008-06, Vol.358 (23), p.2457-2467

2008

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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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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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Characterization of currently marketed heparin products: analysis of molecular weight and heparinase-I digest patterns

Analytical and bioanalytical chemistry, 2011-11, Vol.401 (8), p.2445-2454

2011

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Characterization of currently marketed heparin products: key tests for quality assurance

Analytical and bioanalytical chemistry, 2011-01, Vol.399 (2), p.581-591

2011

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Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

The AAPS journal, 2016-03, Vol.18 (2), p.528-543

2016

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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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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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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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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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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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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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Algorithms for Validating Chiral Properties of Insulins

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

1999

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Class Modeling Analysis of Heparin ^sup 1^H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques

Analytical chemistry (Washington), 2011-02, Vol.83 (3), p.1030

2011

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Class Modeling Analysis of Heparin 1 H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques

Analytical chemistry (Washington), 2011-02, Vol.83 (3), p.1030-1039

2011

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Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

Journal of pharmaceutical sciences, 2015-03, Vol.104 (3), p.832

2015

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In vitro study of nicotine release from smokeless tobacco

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

1998

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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

The US regulatory and pharmacopeia response to the global heparin contamination crisis

Regulatory and Quality Considerations for Continuous Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen

Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

Emerging Applications and Regulatory Strategies for Advanced Medicines Manufacturing – Towards the Development of a Platform Approach

Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events

Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System

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

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

Characterization of currently marketed heparin products: analysis of molecular weight and heparinase-I digest patterns

Characterization of currently marketed heparin products: key tests for quality assurance

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

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

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

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

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

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

Algorithms for Validating Chiral Properties of Insulins

Class Modeling Analysis of Heparin ^sup 1^H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques

Class Modeling Analysis of Heparin 1 H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques

Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

In vitro study of nicotine release from smokeless tobacco

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