Concepedia
Statistics
Publications
5
Citations
250
H-Index
Active since
2010
Affiliations
European Medicines Agency(Current)
United States Food and Drug Administration
Amgen (United States)
Medical University of Vienna
Marisa Papaluca‐Amati is an author at European Medicines Agency specializing in pharmacy, pharmaceutical policy, and drug approval.
Publications per year
2010–2019
Towards consensus practices to qualify safety biomarkers for use in early drug development
Frank D. Sistare, Frank Dieterle, Sean P. Troth et al. · Nature Biotechnology · 2010 · 121 citations
Pharmacy, Pharmacology, Regulatory Pharmacy +16
Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency
Olivier Collignon, Franz Koenig, Armin Koch et al. · Trials · 2018 · 48 citations · Full text
Pharmacy, Pharmaceutical Policy, Clinical Trial Regulation +14
Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union
Francesco Pignatti, Falk Ehmann, Robert Hemmings et al. · Clinical Cancer Research · 2014 · 44 citations
Law, Health Law, Oncology +17
Learning from Product Labels and Label Changes: How to Build Pharmacogenomics into Drug-Development Programs
Linda Surh, Michael Pacanowski, Susanne B. Haga et al. · Pharmacogenomics · 2010 · 21 citations
Medicine, Pharmaceutical Policy, Pharmacology +17
Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model
Philip A. Hines, Richard H. Guy, Angela Brand et al. · British Journal of Clinical Pharmacology · 2019 · 16 citations · Full text
Pharmacy, Pharmaceutical Policy, Regulatory Policy +16
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