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How Often Do Safety Signals Occur by Chance in First‐in‐Human Trials?

Clinicians working on first‐in‐human clinical studies need to be able to judge whether safety signals observed on an investigational drug were more likely to have occurred by chance or to have been caused by the drug. We retrospectively reviewed 84 Novartis studies including 1,234 healthy volunteers...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:Clin Transl Sci
Egile Nagusiak: Clayton, Gemma L., Schachter, Asher D., Magnusson, Baldur, Li, Yue, Colin, Laurence
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: John Wiley and Sons Inc. 2018
Gaiak:
Sarrera elektronikoa:https://ncbi.nlm.nih.gov/pmc/articles/PMC6132364/
https://ncbi.nlm.nih.gov/pubmed/29702733
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12558
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