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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...

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Dettagli Bibliografici
Pubblicato in:Int J Environ Res Public Health
Autori principali: Ollier, Adrien, Zohar, Sarah, Morita, Satoshi, Ursino, Moreno
Natura: Artigo
Lingua:Inglês
Pubblicazione: MDPI 2021
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC7916097/
https://ncbi.nlm.nih.gov/pubmed/33572323
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3390/ijerph18041639
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