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Editorial: Reviews in: regulatory science.
Kerpel-Fronius S, Stoyanova-Beninska V, Giannuzzi V, Sun Z. Kerpel-Fronius S, et al. Among authors: stoyanova beninska v. Front Med (Lausanne). 2023 May 16;10:1206753. doi: 10.3389/fmed.2023.1206753. eCollection 2023. Front Med (Lausanne). 2023. PMID: 37261118 Free PMC article. No abstract available.
Regulatory Standards in Orphan Medicinal Product Designation in the EU.
Tsigkos S, Mariz S, Sheean ME, Larsson K, Magrelli A, Stoyanova-Beninska V. Tsigkos S, et al. Front Med (Lausanne). 2021 Jun 25;8:698534. doi: 10.3389/fmed.2021.698534. eCollection 2021. Front Med (Lausanne). 2021. PMID: 34249982 Free PMC article. Review.
Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Sheean ME, Naumann-Winter F, Capovilla G, Kalland ME, Malikova E, Mariz S, Matusevicius D, Nistico R, Schwarzer-Daum B, Tsigkos S, Tzogani K, Larsson K, Magrelli A, Stoyanova-Beninska V. Sheean ME, et al. Front Med (Lausanne). 2021 Aug 27;8:744625. doi: 10.3389/fmed.2021.744625. eCollection 2021. Front Med (Lausanne). 2021. PMID: 34513895 Free PMC article.
What regulatory science can bring for CNS drug development.
Gispen-de Wied C, Stoyanova-Beninska V. Gispen-de Wied C, et al. Eur Neuropsychopharmacol. 2015 Jul;25(7):967-8. doi: 10.1016/j.euroneuro.2015.04.024. Epub 2015 May 5. Eur Neuropsychopharmacol. 2015. PMID: 26024929 No abstract available.
31 results