Get started
Author

Frauke Naumann‐Winter

Observed names: Frauke Naumann-Winter, Naumann-Winter Frauke, Naumann-Winter, Frauke
ORCID: 0000-0003-0913-1157
Observed ORCID: 0000-0003-0913-1157
OpenAlex ID: A5086606252
First-line tandem high-dose chemotherapy and autologous stem cell transplantation versus single high-dose chemotherapy and autologous stem cell transplantation in multiple myeloma, a systematic review of controlled studies
2012 · Frauke Naumann-Winter, Alexander Greb, et al. · Cochrane Database of Systematic Reviews · 47
PDF
Real‐World Evidence to Support EU Regulatory Decision Making—Results From a Pilot of Regulatory Use Cases
2024 · Stefanie Prilla, Sophie Groeneveld, et al. · Clinical Pharmacology & Therapeutics · 44
PDF
Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective
2014 · Niels Eckstein, Lea Röper, et al. · Journal of Experimental & Clinical Cancer Research · 44
PDF
Assessment of significant benefit for orphan medicinal products by European regulators may support subsequent relative effectiveness assessments by health technology assessment organizations
2020 · Rick A. Vreman, Angela S. de Ruijter, et al. · Drug Discovery Today · 29
PDF
Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe
2017 · Laura Fregonese, Lesley Greene, et al. · Drug Discovery Today · 28
The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products
2023 · Gloria M. Palomo, Tomas Pose-Boirazian, et al. · Molecular Therapy · 17
Licensing of Orphan Medicinal Products—Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021
2022 · Frauke Naumann-Winter, Franziska Wolter, et al. · Frontiers in Pharmacology · 13
Defining orphan conditions in the context of the European orphan regulation: challenges and evolution
2018 · Daniel J. O’Connor, Maria E. Sheean, et al. · Nature Reviews Drug Discovery · 13
Establishing rarity in the context of orphan medicinal product designation in the European Union
2017 · Stelios Tsigkos, Matthias Philipp Hofer, et al. · Drug Discovery Today · 13
Establishing medical plausibility in the context of orphan medicines designation in the European Union
2014 · Stelios Tsigkos, Segundo Mariz, et al. · Orphanet Journal of Rare Diseases · 11
PDF
Advancing rare disease treatment: EMA’s decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation
2024 · Maria Elisabeth Kalland, Tomas Pose-Boirazian, et al. · Gene Therapy · 9
PDF
Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union
2017 · Benedetta Polsinelli, Stelios Tsigkos, et al. · Orphanet Journal of Rare Diseases · 7
PDF
Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective
2021 · Maria E. Sheean, Frauke Naumann-Winter, et al. · Frontiers in Medicine · 5
PDF
Evidenzbasierte Arzneimittelversorgung bei Seltenen Erkrankungen: die Rolle der Digitalisierung
2022 · Frauke Naumann-Winter, Thomas Kaiser, et al. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 4
PDF
Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations
2017 · Andrea Ecker, Segundo Mariz, et al. · Archives of Disease in Childhood · 2
Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective
2014 · Niels Eckstein, Lea Röper, et al. · Generics and Biosimilars Initiative Journal · 2
PDF
Navigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe
2024 · Gloria M. Palomo, Tomas Pose-Boirazian, et al. · Molecular Therapy · 1
HTA183 HTA and Regulatory Perspectives on Robustness of Evidence and Management of Uncertainties
2025 · David McConnell, Dominik Karres, et al. · Value in Health
Hta and Regulatory Perspectives on Robustness of Evidence and Management of Uncertainties
2025 · McConnell, David, Karres, Dominik, et al. · Lirias
Adressen
2021 · Tim Theodor Albert Bender, Sarah Bernsen, et al. · Elsevier eBooks
Erratum to: Establishing medical plausibility in the context of orphan medicines designation in the European Union
2015 · Stelios Tsigkos, Segundo Mariz, et al. · Orphanet Journal of Rare Diseases
PDF
Antibiotics plus colony stimulating factors versus antibiotics alone for the prevention of infections in cancer patients receiving myelosuppressive chemotherapy or haematopoetic stem cell transplantation
2012 · Christine Herbst, Frauke Naumann-Winter, et al. · Cochrane Database of Systematic Reviews
Works count: 22
Citation count: 289
H-index: 10
I10-index: 10
Year
Topic
Type