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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...
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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2012
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Materias: | |
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 |
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