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Estimating Similarity of Dose–Response Relationships in Phase I Clinical Trials—Case Study in Bridging Data Package
Bridging studies are designed to fill the gap between two populations in terms of clinical trial data, such as toxicity, efficacy, comorbidities and doses. According to ICH-E5 guidelines, clinical data can be extrapolated from one region to another if dose–reponse curves are similar between two popu...
Autores principales: | Ollier, Adrien, Zohar, Sarah, Morita, Satoshi, Ursino, Moreno |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7916097/ https://www.ncbi.nlm.nih.gov/pubmed/33572323 http://dx.doi.org/10.3390/ijerph18041639 |
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