A Mechanistic, Model-Based Approach to Safety Assessment in Clinical Development

Assessing the safety of pharmacotherapies is a primary goal of clinical trials in drug development. The low frequency of relevant side effects, however, often poses a significant challenge for risk assessment. Methodologies allowing robust extrapolation of safety statistics based on preclinical data...

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Detalles Bibliográficos
Autores principales: Lippert, J, Brosch, M, von Kampen, O, Meyer, M, Siegmund, H.-U, Schafmayer, C, Becker, T, Laffert, B, Görlitz, L, Schreiber, S, Neuvonen, P J, Niemi, M, Hampe, J, Kuepfer, L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2012
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600730/
https://www.ncbi.nlm.nih.gov/pubmed/23835795
http://dx.doi.org/10.1038/psp.2012.14

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600730/
https://www.ncbi.nlm.nih.gov/pubmed/23835795
http://dx.doi.org/10.1038/psp.2012.14

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