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Qdossier Qsauri
"H"

human pharmacology
Guideline or reference source
EMA Glossary of terms
Definition
A type of clinical study where a new medicine is given to humans for the first time, usually in healthy volunteers. It looks at the way the medicine is dealt with by the body, its main effects and main side effects.   NOTE Qdossier: definition originates from EMA glossary of terms on "Phase 1 Clinical Trial"
Used For
first-in-human study
first-in-man study
phase 1 clinical trial
Broader Term
trial phase
Related Term
open-label study
therapeutic confirmatory
 

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