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...

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Detalles Bibliográficos
Autores principales: Ollier, Adrien, Zohar, Sarah, Morita, Satoshi, Ursino, Moreno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
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

Internet

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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