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Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

2024 . Herzig, Markus | Eisenhofer, Simone | Ruschkowski, Meike | Neubert, Antje | Bertsche, Astrid | Bertsche, Thilo | Neininger, Martina

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 . Naumann-Winter, Frauke | Wolter, Franziska | Hermes, Ulrike | Malikova, Eva | Lilienthal, Nils | Meier, Tania | Kalland, Maria Elisabeth | Magrelli, Armando

Regulatory Requirements for the Quality of Allergen Products for Allergen Immunotherapy of Food Allergy

2021 . Englert, Lisa | Mahler, Vera | Bonertz, Andreas

Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection

2021 . Huber, Cynthia | Friede, Tim | Stingl, Julia | Benda, Norbert

Accelerated Development of COVID-19 Vaccines: Technology Platforms, Benefits, and Associated Risks

2021 . Wagner, Ralf | hildt, eberhard | Grabski, Elena | Sun, Yuansheng | Meyer, Heidi | Lommel, Annette | Keller-Stanislawski, Brigitte | Müller-Berghaus, Jan | Cichutek, Klaus

Assessing consistency in clinical trials with two subgroups and binary endpoints: A new test within the logistic regression model

2020 . Grill, Susann | Ring, Arne | Brannath, Werner | Scharpenberg, Martin

The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

2020 . Hennermann, Julia B. | Guffon, Nathalie | Cattaneo, Federica | Ceravolo, Ferdinando | Borgwardt, Line | Lund, Allan M. | Gil-Campos, Mercedes | Tylki-Szymanska, Anna | Muschol, Nicole M.

Chimäre Antigenrezeptoren (CARs) in der Onkologie: eine Übersicht zu klinischer Anwendung und neuen Entwicklungen

2020 . Michels, Alexander | Hartmann, Jessica | Buchholz, Christian J.

In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme

2020 . Herbert Afegenwi, Mbunkah | Reinhardt, Jens | Kafere, Chancelar | Scheiblauer, Heinrich | Prat, Irena | Nübling, Claudius Micha

Annual Bleeding Rates: Pitfalls of Clinical Trial Outcomes in Hemophilia Patients

2020 . Keipert, Christine | Müller-Olling, Mirco | Gauly, Franca | Arras-Reiter, Cornelia | Hilger, Anneliese

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