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Use of pharmaceutical salts and cocrystals to address the issue of poor solubility

International journal of pharmaceutics, 2013-08, Vol.453 (1), p.88-100

2013

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Analytical advances in pharmaceutical impurity profiling

European journal of pharmaceutical sciences, 2016-05, Vol.87, p.118-135

2016

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Pharmaceutical excipients — quality, regulatory and biopharmaceutical considerations

European journal of pharmaceutical sciences, 2016-05, Vol.87, p.88-99

2016

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Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

Regulatory toxicology and pharmacology, 2019-04, Vol.103, p.325-329

2019

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Tolerability of risk: A commentary on the nitrosamine contamination issue

Journal of pharmaceutical sciences, 2021-06, Vol.110 (6), p.2311-2328

2021

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Methodology of oral formulation selection in the pharmaceutical industry

European journal of pharmaceutical sciences, 2016-05, Vol.87, p.136-163

2016

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Recent advances and potential applications of modulated differential scanning calorimetry (mDSC) in drug development

European journal of pharmaceutical sciences, 2016-05, Vol.87, p.164-173

2016

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Is Avoidance of Genotoxic Intermediates/Impurities Tenable for Complex, Multistep Syntheses?

Organic process research & development, 2015-11, Vol.19 (11), p.1437-1446

2015

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Medicines for Pediatric Patients—Biopharmaceutical, Developmental, and Regulatory Considerations

Journal of pharmaceutical sciences, 2017-04, Vol.106 (4), p.950-960

2017

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Antibiotic Resistance: The Need For a Global Strategy

Journal of pharmaceutical sciences, 2016-08, Vol.105 (8), p.2278-2287

2016

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The solid-state continuum: a perspective on the interrelationships between different solid-state forms in drug substance and drug product

Journal of pharmacy and pharmacology, 2015-06, Vol.67 (6), p.757-772

2015

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Development and validation of an automated static headspace gas chromatography–mass spectrometry (SHS-GC–MS) method for monitoring the formation of ethyl methane sulfonate from ethanol and methane sulfonic acid

Journal of pharmaceutical and biomedical analysis, 2008-12, Vol.48 (5), p.1339-1344

2008

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Assessment of Predictivity of Semiquantitative Risk Assessment Tool: Pazopanib Hydrochloride Genotoxic Impurities

Organic process research & development, 2013-08, Vol.17 (8), p.1036-1041

2013

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Do Carboxylic/Sulfonic Acid Halides Really Present a Mutagenic and Carcinogenic Risk as Impurities in Final Drug Products?

Organic process research & development, 2015-11, Vol.19 (11), p.1495-1506

2015

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The Utility of Sulfonate Salts in Drug Development

Journal of pharmaceutical sciences, 2010-07, Vol.99 (7), p.2948-2961

2010

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Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives

Organic process research & development, 2015-11, Vol.19 (11), p.1486-1494

2015

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ICH Quality Guidelines: An Implementation Guide

Andrew Teasdale, David Elder, Raymond W. Nims

First edition., 2017

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Developing paediatric medicines: identifying the needs and recognizing the challenges

Journal of pharmacy and pharmacology, 2007-08, Vol.59 (8), p.1043-1055

2007

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Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation

Journal of pharmacy and pharmacology, 2009-03, Vol.61 (3), p.269-278

2009

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A Detailed Study of Sulfonate Ester Formation and Solvolysis Reaction Rates and Application toward Establishing Sulfonate Ester Control in Pharmaceutical Manufacturing Processes

Organic process research & development, 2010-07, Vol.14 (4), p.999-1007

2010

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Analytical control strategies for mutagenic impurities: Current challenges and future opportunities?

TrAC, Trends in analytical chemistry (Regular ed.), 2018-04, Vol.101, p.66-84

2018

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Mechanism and Processing Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation

Organic process research & development, 2009-05, Vol.13 (3), p.429-433

2009

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Pharmaceutical Applications of Ion-Exchange Resins

Journal of chemical education, 2005-04, Vol.82 (4), p.575

Elder, David P

2005

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Is there a Real Case for Cumulative Control of Structurally Related Genotoxic Impurities?

Organic process research & development, 2010-07, Vol.14 (4), p.1037-1045

2010

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Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API)

Journal of pharmaceutical and biomedical analysis, 2008-12, Vol.48 (4), p.1082-1089

2008

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Use of pharmaceutical salts and cocrystals to address the issue of poor solubility

Analytical advances in pharmaceutical impurity profiling

Pharmaceutical excipients — quality, regulatory and biopharmaceutical considerations

Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

Tolerability of risk: A commentary on the nitrosamine contamination issue

Methodology of oral formulation selection in the pharmaceutical industry

Recent advances and potential applications of modulated differential scanning calorimetry (mDSC) in drug development

Is Avoidance of Genotoxic Intermediates/Impurities Tenable for Complex, Multistep Syntheses?

Medicines for Pediatric Patients—Biopharmaceutical, Developmental, and Regulatory Considerations

Antibiotic Resistance: The Need For a Global Strategy

The solid-state continuum: a perspective on the interrelationships between different solid-state forms in drug substance and drug product

Development and validation of an automated static headspace gas chromatography–mass spectrometry (SHS-GC–MS) method for monitoring the formation of ethyl methane sulfonate from ethanol and methane sulfonic acid

Assessment of Predictivity of Semiquantitative Risk Assessment Tool: Pazopanib Hydrochloride Genotoxic Impurities

Do Carboxylic/Sulfonic Acid Halides Really Present a Mutagenic and Carcinogenic Risk as Impurities in Final Drug Products?

The Utility of Sulfonate Salts in Drug Development

Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives

ICH Quality Guidelines: An Implementation Guide

Developing paediatric medicines: identifying the needs and recognizing the challenges

Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation

A Detailed Study of Sulfonate Ester Formation and Solvolysis Reaction Rates and Application toward Establishing Sulfonate Ester Control in Pharmaceutical Manufacturing Processes

Analytical control strategies for mutagenic impurities: Current challenges and future opportunities?

Mechanism and Processing Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation

Pharmaceutical Applications of Ion-Exchange Resins

Is there a Real Case for Cumulative Control of Structurally Related Genotoxic Impurities?

Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API)

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