Reviewing the role of healthy volunteer studies in drug development

Reviewing the role of healthy volunteer studies in drug development

Abstract Background With the exception of genotoxic oncology drugs, first-in-human, Phase 1 clinical studies of investigational drugs have traditionally been conducted in healthy volunteers (HVs). The primary goal of these studies is to investigate the pharmacokinetics and pharmacodynamics of a nove...

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Bibliographic Details
Main Authors: Joyson J. Karakunnel, Nam Bui, Latha Palaniappan, Keith T. Schmidt, Kenneth W. Mahaffey, Briggs Morrison, William D. Figg, Shivaani Kummar
Format: Article
Language:English
Published: BMC 2018-12-01
Series:Journal of Translational Medicine
Subjects:
Healthy volunteer
Phase 1
First-in-human
Safety
Toxicity
Pharmacokinetic
Online Access:http://link.springer.com/article/10.1186/s12967-018-1710-5

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