Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be res...

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Detalles Bibliográficos
Autores principales: Moseley, Jane, Vamvakas, Spiros, Berntgen, Michael, Cave, Alison, Kurz, Xavier, Arlett, Peter, Acha, Virginia, Bennett, Simon, Cohet, Catherine, Corriol‐Rohou, Solange, Du Four, Emma, Lamoril, Christelle, Langeneckert, Anja, Koban, Maren, Pasté, Muriel, Sandler, Susan, Van Baelen, Karin, Cangini, Agnese, García, Sonia, Obach, Mercè, Gimenez Garcia, Emmanuel, Varela Lema, Leonor, Jauhonen, Hanna‐Mari, Rannanheimo, Piia, Morrison, Deborah, Van De Casteele, Marc, Strömgren, Anna, Viberg, Anders, Makady, Amr, Guilhaume, Chantal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256124/
https://www.ncbi.nlm.nih.gov/pubmed/32162368
http://dx.doi.org/10.1111/bcp.14279

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