Thomas C. Kühler - Publications, H-index & Citations

Thomas C. Kühler

Sanofi-Aventis

14H指数

30论文数

1.2K被引数

收录论文 17

发表时间

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

IF3.6

2024-03-01

OAAI

Kuhler, Thomas C.; Ateka, Aritz; Lassoued, Zeineb; Routhier, Francois-Xavier; Mekary-Sawaya, Souha

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

CLINICAL THERAPEUTICS

IF3.6

2022-05-01

OAAI

Kuhler, Thomas C.; Schoenmakers, Marc; Shergold, Oliver; Affolter, Stephan; Bolislis, Winona Rei; Foster, Ruth; Gardner, Paul; Hruschka, Svenja; Jomini, Thierry; Kaveripakam, Sathish; Mayerhofer, Karl; Scherini, Tomaso; Swierczynska, Marta; Vandal, Gretchen; Fuerst-Ladani, Shayesteh

Rolling Reviews During COVID-19: The European Union Experience in a Global Context 新型冠状病毒肺炎期间的滚动评论: 全球背景下的欧盟经验

CLINICAL THERAPEUTICS

IF3.6

2022-03-01

OAAI

Marinus, Roelie; Mofid, Sarah; Mpandzou, Marya; Kuhler, Thomas C.

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

CLINICAL THERAPEUTICS

IF3.6

2022-02-01

PREAI

Mofid, Sarah; Bolislis, Winona Rei; Kuhler, Thomas C.

Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health-an EFPIA View 动态监管评估: 为患者和公共卫生利益发展欧洲监管框架-EFPIA观点

CLINICAL THERAPEUTICS

IF3.6

2022-01-01

OAAI

Herrero-Martinez, Esteban; Hussain, Nasir; Le Roux, Nadege; MacDonald, Judith; Mayer, Mark; Palacios, Rodrigo; Kuehler, Thomas C.

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

CLINICAL THERAPEUTICS

IF3.6

2021-12-01

OAAI

Mofid, Sarah; Bolislis, Winona Rei; Brading, Clive; Hamilton, Nigel; Hardit, Cyril; Nagaoka, Makoto; Parain, Julien; Zanta, Maria; Kuhler, Thomas C.

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?欧洲药品管理局和美国食品和药物管理局决策的透明度: 是否有可能从公共评估报告中识别出已批准适应症的差异的理由？

CLINICAL THERAPEUTICS

IF3.6

2021-05-01

OAAI

Bujar, Magda; Ferragu, Sara; McAuslane, Neil; Liberti, Lawrence; Kuhler, Thomas C.

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2021-02-02

OAAI

Bolislis, Winona Rei; Bejeuhr, Gesine; Benzaghou, Fawzi; Corriol-Rohou, Solange; Herrero-Martinez, Esteban; Hildebrand, Heidrun; Hill-Venning, Claire; Hoogland, Hans; Johnson, Craig; Joos, Angelika; Vart, Richard; Le Visage, Genevieve; Kuhler, Thomas C.

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

CLINICAL THERAPEUTICS

IF3.6

2021-01-01

OAAI

Bolislis, Winona Rei; de Lucia, Maria Lucia; Dolz, Felipe; Mo, Runyi; Nagaoka, Makoto; Rodriguez, Heraclio; Woon, May Li; Yu, Wei; Kuhler, Thomas C.

Use of Real-world Data for New Drug Applications and Line Extensions 将真实数据用于新药申请和生产线扩展

CLINICAL THERAPEUTICS

IF3.6

2020-05-01

OAAI

Bolislis, Winona R.; Fay, Myriam; Kuhler, Thomas C.

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

CLINICAL THERAPEUTICS

IF3.6

2019-12-01

OAAI

Bolislis, Winona Rei; Corriol-Rohou, Solange; Hill-Venning, Claire; Hoogland, Hans; Joos, Angelika; King, David; Kitcatt, Victoria; Le Visage, Genevieve; Kuhler, Thomas C.

Are pharmaceuticals potent environmental pollutants? : Part II:: Environmental risk assessments of selected pharmaceutical excipients 药品是潜在的环境污染物吗？: 第二部分:: 选定的药用辅料的环境风险评估

SCIENCE OF THE TOTAL ENVIRONMENT

IF8

2006-07-01

PREAI

Carlsson, Carina; Johansson, Anna-Kanin; Alvan, Gunnar; Bergman, Kerstin; Kuhler, Thomas

Are pharmaceuticals potent environmental pollutants?: Part I:: Environmental risk assessments of selected active pharmaceutical ingredients 药品是否具有潜在的环境污染物？: 第一部分:: 选定活性药物成分的环境风险评估

SCIENCE OF THE TOTAL ENVIRONMENT

IF8

2006-07-01

401

PREAI

Carlsson, Carina; Johansson, Anna-Karin; Alvan, Gunnar; Bergman, Kerstin; Kuhler, Thomas

Novel structures derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as anti-Helicobacter pylori agents, part 1

JOURNAL OF MEDICINAL CHEMISTRY

IF6.8

2002-08-09

PREAI

Kühler, TC; Swanson, M; Christenson, B; Klintenberg, AC; Lamm, B; Fägerhag, J; Gatti, R; Ölwegård-Halvarsson, M; Shcherbuchin, V; Elebring, T; Sjöström, JE

Novel structure's derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as anti-Helicobacter pylori agents, part 2

JOURNAL OF MEDICINAL CHEMISTRY

IF6.8

2002-08-09

PREAI

Carcangue, D; Shue, YK; Wuonola, MA; Uria-Nickelsen, M; Joubran, C; Abedi, JK; Jones, J; Kühler, TC

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

IF6.8

1998-04-29

PREAI

Kühler, TC; Swanson, M; Shcherbuchin, V; Larsson, H; Mellgard, B; Sjöström, JE