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A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

Annals of the New York Academy of Sciences, 2021-10, Vol.1502 (1), p.5-13

2021

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Development of an online p38α mitogen-activated protein kinase binding assay and integration of LC-HR-MS

Analytical and bioanalytical chemistry, 2010-10, Vol.398 (4), p.1771-1780

2010

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Determination and identification of estrogenic compounds generated with biosynthetic enzymes using hyphenated screening assays, high resolution mass spectrometry and off-line NMR

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2010-03, Vol.878 (7), p.667-674

2010

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High temperature liquid chromatography hyphenated with ESI-MS and ICP-MS detection for the structural characterization and quantification of halogen containing drug metabolites

Analytica chimica acta, 2011-07, Vol.698 (1), p.69-76

2011

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Trimethoprim: Novel Reactive Intermediates and Bioactivation Pathways by Cytochrome P450s

Chemical research in toxicology, 2008-11, Vol.21 (11), p.2181-2187

2008

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Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Annals of the New York Academy of Sciences, 2017-11, Vol.1407 (1), p.39-49

2017

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Editorial: Public-Private Partnerships as Drivers of Innovation in Healthcare

Frontiers in medicine, 2019-05, Vol.6, p.114-114

2019

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The European Lead Factory: An updated HTS compound library for innovative drug discovery

Drug discovery today, 2021-10, Vol.26 (10), p.2406-2413

2021

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The European Lead Factory: Results from a decade of collaborative, public–private, drug discovery programs

Drug discovery today, 2024-03, Vol.29 (3), p.103886-103886, Article 103886

2024

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Automated detection of covalent adducts to human serum albumin by immunoaffinity chromatography, on-line solution phase digestion and liquid chromatography–mass spectrometry

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2007-11, Vol.859 (2), p.147-156

2007

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How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

The AAPS journal, 2014-01, Vol.16 (1), p.15-21

2014

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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

The AAPS journal, 2019-04, Vol.21 (4), p.56, Article 56

2019

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A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence

GaBI Journal, 2019-01, Vol.8 (3), p.128-131

2019

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The similarity question for biologicals and non-biological complex drugs

European journal of pharmaceutical sciences, 2015-08, Vol.76, p.10-17

2015

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Different Pharmaceutical Products Need Similar Terminology

The AAPS journal, 2014-01, Vol.16 (1), p.11-14

2014

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The European Lead Factory: A Blueprint for Public-Private Partnerships in Early Drug Discovery

Frontiers in medicine, 2017-01, Vol.3, p.75-75

2017

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On-line electrochemistry–bioaffinity screening with parallel HR-LC-MS for the generation and characterization of modified p38α kinase inhibitors

Analytical and bioanalytical chemistry, 2012-04, Vol.403 (2), p.367-375

2012

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Selective quantitative bioanalysis of proteins in biological fluids by on-line immunoaffinity chromatography–protein digestion–liquid chromatography–mass spectrometry

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2006-01, Vol.830 (2), p.262-269

2006

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Structural elucidation of biologically active neomycin N-octyl derivatives in a regioisomeric mixture by means of liquid chromatography/ion trap time-of-flight mass spectrometry

Rapid communications in mass spectrometry, 2010-05, Vol.24 (10), p.1439-1446

2010

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Is the EU ready for non-biological complex drug products?

GaBI Journal, 2016-09, Vol.5 (3), p.101-102

2016

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Complex Drugs: What Are They and Why Do They Need Special Attention?

Acta Pharmaceutica Hungarica, 2021-11, Vol.91 (3-4), p.110-111

De Vlieger, Jon S. B.

2021

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Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section

GaBI Journal, 2015-12, Vol.4 (4), p.167-170

2015

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Corrigendum to “The European Lead Factory: An updated HTS compound library for innovative drug discovery” [Drug Discov. Today 26(10) (2021) 2406–2413]

Drug discovery today, 2023-08, Vol.28 (8), p.103257-103257, Article 103257

2023

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IMI European Lead Factory - democratizing access to high-throughput screening

Nature reviews. Drug discovery, 2022-04, Vol.21 (4), p.245-246

2022

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Application of drug metabolising mutants of cytochrome P450 BM3 (CYP102A1) as biocatalysts for the generation of reactive metabolites

Chemico-biological interactions, 2008-01, Vol.171 (1), p.96-107

2008

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A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

Development of an online p38α mitogen-activated protein kinase binding assay and integration of LC-HR-MS

Determination and identification of estrogenic compounds generated with biosynthetic enzymes using hyphenated screening assays, high resolution mass spectrometry and off-line NMR

High temperature liquid chromatography hyphenated with ESI-MS and ICP-MS detection for the structural characterization and quantification of halogen containing drug metabolites

Trimethoprim: Novel Reactive Intermediates and Bioactivation Pathways by Cytochrome P450s

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Editorial: Public-Private Partnerships as Drivers of Innovation in Healthcare

The European Lead Factory: An updated HTS compound library for innovative drug discovery

The European Lead Factory: Results from a decade of collaborative, public–private, drug discovery programs

Automated detection of covalent adducts to human serum albumin by immunoaffinity chromatography, on-line solution phase digestion and liquid chromatography–mass spectrometry

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence

The similarity question for biologicals and non-biological complex drugs

Different Pharmaceutical Products Need Similar Terminology

The European Lead Factory: A Blueprint for Public-Private Partnerships in Early Drug Discovery

On-line electrochemistry–bioaffinity screening with parallel HR-LC-MS for the generation and characterization of modified p38α kinase inhibitors

Selective quantitative bioanalysis of proteins in biological fluids by on-line immunoaffinity chromatography–protein digestion–liquid chromatography–mass spectrometry

Structural elucidation of biologically active neomycin N-octyl derivatives in a regioisomeric mixture by means of liquid chromatography/ion trap time-of-flight mass spectrometry

Is the EU ready for non-biological complex drug products?

Complex Drugs: What Are They and Why Do They Need Special Attention?

Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section

Corrigendum to “The European Lead Factory: An updated HTS compound library for innovative drug discovery” [Drug Discov. Today 26(10) (2021) 2406–2413]

IMI European Lead Factory - democratizing access to high-throughput screening

Application of drug metabolising mutants of cytochrome P450 BM3 (CYP102A1) as biocatalysts for the generation of reactive metabolites

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