Zobrazeno 1 - 9 of 9 pro vyhledávání: '"Stiina, Aarum"'
1
Marketing authorisation of orphan medicines in Europe from 2000 to 2013
Autor: Stiina Aarum, Franz Koenig, Hanna Hedman, Matthias P. Hofer, Thorsten Vetter, Spiros Vamvakas, Martin Posch, Maria Mavris, Jan Regnstrom
Publikováno v: Drug Discovery Today. 23:424-433
An analysis was performed on a data set of 157 orphan designated medicines with an outcome for marketing authorisation application (MAA) between 2000 and 2013. The intention was to understand the factors associated with marketing authorisation succes
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bf034aa059f2078d1ead0529e544c78
https://doi.org/10.1016/j.drudis.2017.10.012
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2
The orphan framework as a new opportunity: an expert opinion
Autor: Eleonora Dehlink, Laura Fregonese, Bruno Sepodes, Stiina Aarum, Jordi Llinares, Stelios Tsigkos, Segundo Mariz
Publikováno v: Expert Opinion on Orphan Drugs. 2:1181-1186
This is a review of the post-designation incentives framework that exists in Europe under its Orphan Medicinal Designation System. The aim of the article is to review and highlight specific regulatory mechanisms which are used or tailored to help in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f18f21f83c4a28630ded7191381bccf8
https://doi.org/10.1517/21678707.2014.973849
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3
The same annual dose of 292000 IU of vitamin D3(cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D3concentrations and renal function
Autor: Tuula Pekkarinen, Ursula Turpeinen, Esa Hämäläinen, Ville-Valtteri Välimäki, Stiina Aarum, Matti Välimäki, Eliisa Löyttyniemi
Publikováno v: Clinical Endocrinology. 72:455-461
Objective Daily dosing of vitamin D supplements may be difficult among older people. Infrequent administration of 'megadoses' controlled by health care personnel may overcome adherence problem. We compared the efficacy and safety of two oral dosages
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::90edd3152b8955de92b7b3d5e97b6377
https://doi.org/10.1111/j.1365-2265.2009.03637.x
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5
European regulation on orphan medicinal products: 10 years of experience and future perspectives
Autor: Kerstin, Westermark, Birthe Byskov, Holm, Mirjam, Söderholm, Jordi, Llinares-Garcia, Frida, Rivière, Stiina, Aarum, Florence, Butlen-Ducuing, Stelios, Tsigkos, Agnieszka, Wilk-Kachlicka, Cinzia, N'Diamoi, János, Borvendég, David, Lyons, Bruno, Sepodes, Brigitte, Bloechl-Daum, André, Lhoir, Mariana, Todorova, Ioannis, Kkolos, Kateřina, Kubáčková, Heidrun, Bosch-Traberg, Vallo, Tillmann, Veijo, Saano, Emmanuel, Héron, Rembert, Elbers, Miranda, Siouti, Judit, Eggenhofer, Patrick, Salmon, Maurizio, Clementi, Dainis, Krieviņš, Aušra, Matulevičiene, Henri, Metz, Albert Cilia, Vincenti, Albertha, Voordouw, Bożenna, Dembowska-Bagińska, Ana Corrêa, Nunes, Flavia Mirela, Saleh, Tatiana, Foltánová, Martin, Možina, Josep, Torrent i Farnell, Björn, Beerman, Segundo, Mariz, Marie Pauline, Evers, Lesley, Greene, Sigurdur, Thorsteinsson, Lars, Gramstad, Maria, Mavris, Fabrizia, Bignami, Annie, Lorence, Chantal, Belorgey
Publikováno v: Nature reviews. Drug discovery. 10(5)
In 2000, regulation on orphan medicinal products was adopted in the European Union with the aim of benefiting patients who suffer from serious, rare conditions for which there is currently no satisfactory treatment. Since then, more than 850 orphan d
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::89d8998cffc4d17daac011c4aa2f5623
https://pubmed.ncbi.nlm.nih.gov/21532564
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6
European Medicines Agency support mechanisms fostering orphan drug development
Autor: Frida Rivière, Jordi Llinares-Garcia, Florence Butlen-Ducuing, Stiina Aarum
Publikováno v: Drug newsperspectives. 23(1)
A legislative framework introducing European public health measures on orphan medicinal products came into force in the European Union in April 2000. The aim of the orphan legislation is to stimulate research and development of medicinal products for
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::27a6b58dccd442983fcc1c09884a81fb
https://pubmed.ncbi.nlm.nih.gov/20155221
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7
The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function
Autor: Tuula, Pekkarinen, Ville-Valtteri, Välimäki, Stiina, Aarum, Ursula, Turpeinen, Esa, Hämäläinen, Eliisa, Löyttyniemi, Matti J, Välimäki
Publikováno v: Clinical endocrinology. 72(4)
Daily dosing of vitamin D supplements may be difficult among older people. Infrequent administration of 'megadoses' controlled by health care personnel may overcome adherence problem. We compared the efficacy and safety of two oral dosages (800 IU da
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::86eb75ec2fb6e059697d5f2e036389b5
https://pubmed.ncbi.nlm.nih.gov/19486025
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8
Use of biomarkers in the context of orphan medicines designation in the European Union
Autor: Tatiana Foltanova, Albertha Voordouw, Laura Fregonese, Bruno Sepodes, André Lhoir, Segundo Mariz, Daniel O’Connor, Jordi Llinares, Stelios Tsigkos, Pauline J Evers, Bożenna Dembowska-Bagińska, Ana Corrêa-Nunes, Kerstin Westermark, Rembert Elbers, Stiina Aarum
Publikováno v: Orphanet Journal of Rare Diseases
The use of biomarkers within the procedures of the Committee of Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is discussed herein. The applications for Orphan Medicinal Product designation in the EU are evaluated at two stag
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96538163b912d4dee7bc23aa613fa7bc
http://europepmc.org/articles/PMC3907589
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9
Establishing medical plausibility in the context of orphan medicines designation in the European Union
Autor: Stelios, Tsigkos, Segundo, Mariz, Jordi, Llinares, Laura, Fregonese, Stiina, Aarum, Frauke, Naumann-Winter, Naumann-Winter, Frauke, Kerstin, Westermark, Bruno, Sepodes
Publikováno v: Orphanet Journal of Rare Diseases
In the European Union, sponsors have the responsibility to demonstrate the "intention to diagnose, prevent or treat" a serious and rare condition before the Committee of Orphan Medicinal Products (COMP), for a medicinal product to meet the criteria f
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bfeeefe82b62188ca8ffc12ae2499fb
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