The use of albuminuria and proteinuria for regulatory clinical decision making: a perspective from European regulators
Frank Holtkamp, Hrefna Guðmundsdóttir, Karin Janssen van Doorn, Thorsten Vetter
0 citationsNephrology Dialysis Transplantation
Thorsten Vetter
Informations fournies par OpenAlex. Research Africa ne déduit ni nationalité, ni poste, ni coordonnées personnelles.
21Publications signalées
1197Citations signalées
1Affiliations récentes
Institutions déclarées
Domaines associés
Health Systems, Economic Evaluations, Quality of LifeStatistical Methods in Clinical TrialsChronic Kidney Disease and DiabetesPharmaceutical Economics and PolicyBiosimilars and Bioanalytical Methods
Publications récentes
Optimizing Patient Registries for Regulatory Decision Making ‐ Key Learnings From an HMA / EMA Multistakeholder Workshop
Kelly Plueschke, Carla J. Jonker, Hanna Kankanen, Thorsten Vetter et autres
15 citationsClinical Pharmacology & Therapeutics
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency
Cynthia Huber, J. Zinserling, Norbert Benda, Thorsten Vetter et autres
6 citationsClinical Pharmacology & Therapeutics
Identifying and overcoming challenges in the EMA’s qualification of novel methodologies: a two-year review
Ana Drmić, Riccardo Saccà, Thorsten Vetter, Falk Ehmann
9 citationsFrontiers in Pharmacology
Patient‐reported, observer‐reported and performance outcomes in qualification procedures at the European Medicines Agency 2013–2018
Marta Guerreiro Santano Ramos Da Silva, Jane Moseley, Thorsten Vetter, Jan Regnström et autres
6 citationsBritish Journal of Clinical Pharmacology
Reverse Engineering of Digital Measures: Inviting Patients to the Conversation
Ieuan Clay, Nele Peerenboom, Dana E. Connors, Steven Bourke et autres
17 citationsDigital Biomarkers
Evolving regulatory perspectives on digital health technologies for medicinal product development
Seya Colloud, Thomas Metcalfe, Scott Askin, Shibeshih Belachew et autres
57 citationsnpj Digital Medicine
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
Shannon Thor, Thorsten Vetter, Anabela Marcal, Sandra L. Kweder
10 citationsTherapeutic Innovation & Regulatory Science
Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
Natalie M. Hendrikse, Jordi Llinares Garcia, Thorsten Vetter, A. J. B. Humphreys et autres
21 citationsFrontiers in Medicine
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
Elisabeth Bakker, Natalie M. Hendrikse, Falk Ehmann, Daniëlla S. van der Meer et autres
60 citationsClinical Pharmacology & Therapeutics
Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting
Elisabeth Bakker, Peter G. M. Mol, J.M. Valente Nabais, Thorsten Vetter et autres
2 citationsFrontiers in Pharmacology
Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology—Children and Adolescents (SONG-KIDS) consensus workshops
Camilla S. Hanson, Jonathan C. Craig, Charlotte Logeman, Aditi Sinha et autres
99 citationsKidney International
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