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БИОпрепараты. Профилактика, диагностика, лечение

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Орфанные препараты, принципы их регистрации и применения

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Об авторах

Александр Алексеевич Солдатов
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Россия


Жанна Ильдаровна Авдеева
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Россия


Наталья Александровна. Алпатова
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Россия


Николай Васильевич Медуницын
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Россия


Светлана Леонидовна Лысикова
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Россия


Список литературы

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41. Kim S. The Orphan Drug Act: How the FDA Unlawfully Usurped Market Exclusivity. Nw J Tech & Intell Prop 2013; 11 (6 Article 3): 541-59.

42. Tambuyzer E. Rare diseases, orphan drugs and their regulation: questions and misconceptions. Nat Rev Drug Discov 2010; 9(12): 921-9.


Рецензия

Для цитирования:


Солдатов А.А., Авдеева Ж.И., Алпатова Н.А., Медуницын Н.В., Лысикова С.Л. Орфанные препараты, принципы их регистрации и применения. БИОпрепараты. Профилактика, диагностика, лечение. 2015;(3):4-16.

For citation:


Soldatov A.A., Avdeeva Z.I., Alpatova N.A., Medunitsyn N.V., Lysikova S.L. Orphan drugs and the principles of their marketing authorization procedures and clinical use. BIOpreparations. Prevention, Diagnosis, Treatment. 2015;(3):4-16. (In Russ.)

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