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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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Podrobná bibliografie
Vydáno v:Int J Environ Res Public Health
Hlavní autoři: Ollier, Adrien, Zohar, Sarah, Morita, Satoshi, Ursino, Moreno
Médium: Artigo
Jazyk:Inglês
Vydáno: MDPI 2021
Témata:
On-line přístup: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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