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Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View

Clinical therapeutics, 2022-01, Vol.44 (1), p.132-138

2022

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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

BMJ open, 2019-11, Vol.9 (11), p.e028677-e028677

2019

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Use of Real-world Data for New Drug Applications and Line Extensions

Clinical therapeutics, 2020-05, Vol.42 (5), p.926-938

2020

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Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA

Clinical therapeutics, 2022-02, Vol.44 (2), p.306-322

2022

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Rolling Reviews During COVID-19: The European Union Experience in a Global Context

Clinical therapeutics, 2022-03, Vol.44 (3), p.352-363

2022

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Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM

Clinical therapeutics, 2024-03, Vol.46 (3), p.208-216

2024

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Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?

Clinical therapeutics, 2021-05, Vol.43 (5), p.888-905

2021

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Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

Clinical therapeutics, 2021-01, Vol.43 (1), p.124-139

2021

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The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting

Clinical therapeutics, 2021-12, Vol.43 (12), p.2046-2063

2021

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Foreword Special Section on "Evolving Trends in Electrical Modeling, Validation, and Signal and Power Integrity Analysis in Electronic Packaging and Systems"

IEEE transactions on components, packaging, and manufacturing technology (2011), 2023-10, Vol.13 (10), p.1531-1532

2023

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Are pharmaceuticals potent environmental pollutants? part I: Environmental risk assessments of selected active pharmaceutical ingredients

The Science of the total environment, 2006-07, Vol.364 (1-3), p.67-87

2006

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Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

Clinical pharmacology and therapeutics, 2021-10, Vol.110 (4), p.871-879

2021

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Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association

Clinical therapeutics, 2022-05, Vol.44 (5), p.768-782

2022

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Orphan Medicines for Pediatric Use: A Focus on the European Union

Clinical therapeutics, 2019-12, Vol.41 (12), p.2630-2642

2019

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From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety

Therapeutic innovation & regulatory science, 2020-07, Vol.54 (4), p.831-838

2020

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Novel Structures Derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as Anti-Helicobacter pylori Agents, Part 2

Journal of medicinal chemistry, 2002-09, Vol.45 (19), p.4300-4309

2002

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Structure−Activity Relationship of 2-[[(2-Pyridyl)methyl]thio]-1H- benzimidazoles as Anti Helicobacter pylori Agents in Vitro and Evaluation of their in Vivo Efficacy

Journal of medicinal chemistry, 1998-05, Vol.41 (11), p.1777-1788

1998

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Parameter estimation of an ion-exchange process based on a pseudo probability measure

Optical and quantum electronics, 2022, Vol.54 (6), Article 347

2022

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Novel Structures Derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as Anti-Helicobacter pylori Agents, Part 1

Journal of medicinal chemistry, 2002-09, Vol.45 (19), p.4282-4299

2002

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Analysis and optimisation of bidirectional optical couplers in PCBs

Optical and quantum electronics, 2018-02, Vol.50 (2), p.1-13, Article 109

2018

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Inverse modeling of buried, ion-exchanged glass waveguides using an adjoint method

Optical and quantum electronics, 2018-03, Vol.50 (3), p.1-11, Article 130

2018

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Low loss optical MMI-based splitter based on a semi-analytical modeling approach

Optical and quantum electronics, 2018-02, Vol.50 (2), p.1-16, Article 78

2018

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Modeling multivariate dependencies for manufacturing single-mode I/O structures of integrated MMI-based splitters in glass sheets

Optical and quantum electronics, 2020, Vol.52 (1), Article 15

2020

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Psychometric Properties of the Borderline Symptom List (BSL)

Psychopathology, 2007-02, Vol.40 (2), p.126-132

2007

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Are pharmaceuticals potent environmental pollutants? part II: Environmental risk assessments of selected pharmaceutical excipients

The Science of the total environment, 2006-07, Vol.364 (1-3), p.88-95

2006

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Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

Use of Real-world Data for New Drug Applications and Line Extensions

Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA

Rolling Reviews During COVID-19: The European Union Experience in a Global Context

Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM

Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting

Foreword Special Section on "Evolving Trends in Electrical Modeling, Validation, and Signal and Power Integrity Analysis in Electronic Packaging and Systems"

Are pharmaceuticals potent environmental pollutants? part I: Environmental risk assessments of selected active pharmaceutical ingredients

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association

Orphan Medicines for Pediatric Use: A Focus on the European Union

From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety

Novel Structures Derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as Anti-Helicobacter pylori Agents, Part 2

Structure−Activity Relationship of 2-[[(2-Pyridyl)methyl]thio]-1H- benzimidazoles as Anti Helicobacter pylori Agents in Vitro and Evaluation of their in Vivo Efficacy

Parameter estimation of an ion-exchange process based on a pseudo probability measure

Novel Structures Derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as Anti-Helicobacter pylori Agents, Part 1

Analysis and optimisation of bidirectional optical couplers in PCBs

Inverse modeling of buried, ion-exchanged glass waveguides using an adjoint method

Low loss optical MMI-based splitter based on a semi-analytical modeling approach

Modeling multivariate dependencies for manufacturing single-mode I/O structures of integrated MMI-based splitters in glass sheets

Psychometric Properties of the Borderline Symptom List (BSL)

Are pharmaceuticals potent environmental pollutants? part II: Environmental risk assessments of selected pharmaceutical excipients

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