أخبار
Defining orphan conditions in the context of the European orphan regulation: challenges and evolution
| العنوان: | Defining orphan conditions in the context of the European orphan regulation: challenges and evolution |
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| المؤلفون: | O'Connor, D.J., Sheean, M.E., Hofer, M.P., Tsigkos, S., Mariz, S., Fregonese, L., Larsson, K., Hivert, V., Westermark, K., Naumann-Winter, F., Stoyanova-Beninska, V., Barišić, I., Capovilla, G., Magrelli, A., Sepodes, B. |
| بيانات النشر: | Nature Publishing Group |
| سنة النشر: | 2019 |
| المجموعة: | Max-Delbrueck-Center for Molecular Medicine, Berlin: MDC Repository |
| مصطلحات موضوعية: | Function and Dysfunction of the Nervous System |
| الوصف: | The definition and acceptability of an orphan condition is pivotal for the assessment of European orphan medicinal product designation applications, and consequently the eligibility for incentives. Here, based on the experiences of the Committee for Orphan Medicinal Products, we discuss how to define orphan conditions in the context of the European regulatory framework. |
| نوع الوثيقة: | other non-article part of journal/newspaper |
| اللغة: | unknown |
| العلاقة: | Defining orphan conditions in the context of the European orphan regulation: challenges and evolution. O'Connor, D.J. and Sheean, M.E. and Hofer, M.P. and Tsigkos, S. and Mariz, S. and Fregonese, L. and Larsson, K. and Hivert, V. and Westermark, K. and Naumann-Winter, F. and Stoyanova-Beninska, V. and Barišić, I. and Capovilla, G. and Magrelli, A. and Sepodes, B. Nature Reviews Drug Discovery 18 (7): 479-480. July 2019 |
| DOI: | 10.1038/nrd.2018.128 |
| الإتاحة: | https://doi.org/10.1038/nrd.2018.128Test http://edoc.mdc-berlin.de/17755Test/ https://edoc.mdc-berlin.de/17755Test/ |
| رقم الانضمام: | edsbas.CCC4B720 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1038/nrd.2018.128 |
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