Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

Autor: Caridad Pontes, Juan Manuel Fontanet, Roser Vives, Aranzazu Sancho, Mònica Gómez-Valent, José Ríos, Rosa Morros, Jorge Martinalbo, Martin Posch, Armin Koch, Kit Roes, Katrien Oude Rengerink, Josep Torrent-Farnell, Ferran Torres

Publikováno v: Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-15 (2018)

Abstract Background To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information

Externí odkaz: https://doaj.org/article/31b6e2e0d7194fdca15adacaf444fa52

Simulating Study Data to Support Expected Value of Sample Information Calculations:A Tutorial

Autor: Mark Strong, Anna Heath, Jeremy D. Goldhaber-Fiebert, David Glynn, Nicky J Welton, Natalia Kunst

Publikováno v: Heath, A, Strong, M, Glynn, D, Kunst, N, Welton, N J & Goldhaber-Fiebert, J D 2021, ' Simulating Study Data to Support Expected Value of Sample Information Calculations : A Tutorial ', Medical Decision Making . https://doi.org/10.1177/0272989X211026292
Medical Decision Making

The Expected Value of Sample Information (EVSI) can be used to prioritise avenues for future\ud research and design studies that support medical decision making and offer value for money spent.\ud EVSI is calculated based on three key elements. Two o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1c1f4f66598f3badb2833aed356bee9d
https://research-information.bris.ac.uk/en/publications/032645be-e64e-445f-b87a-acbffa61a76f

Awareness, compatibility and equality as drivers to resilience in sustainable design research

Autor: Mincolelli, G., Giacobone, G. A., Imbesi, S., Marchi, M., Petrocchi, F

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______3709::1f241eb1dfb5492361ff64748bfc0254
https://hdl.handle.net/11392/2464569

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

Autor: Roser Vives, Katrien Oude Rengerink, Josep Torrent-Farnell, Armin Koch, Martin Posch, Caridad Pontes, Rosa Morros, Aranzazu Sancho, José Ríos, M Gómez-Valent, Kit C.B. Roes, Ferran Torres, Jorge Martinalbo, Juan Manuel Fontanet

Publikováno v: Orphanet Journal of Rare Diseases
Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-15 (2018)
Orphanet Journal of Rare Diseases, 13(1). BioMed Central

Background To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a19f21e84788d721daef539cce7ad985
http://europepmc.org/articles/PMC6238348

A Review of “Researching with Children & Young People: Research Design, Methods and Analysis”.

Autor: Abrams, LisaM.¹ (AUTHOR)

Publikováno v: Journal of Educational Research. Mar/Apr2010, Vol. 103 Issue 4, p291-292. 2p.