TY - JOUR AU - Karakunnel, Joyson J. AU - Bui, Nam AU - Palaniappan, Latha AU - Schmidt, Keith T. AU - Mahaffey, Kenneth W. AU - Morrison, Briggs AU - Figg, William D. AU - Kummar, Shivaani PY - 2018 DA - 2018/12/04 TI - Reviewing the role of healthy volunteer studies in drug development JO - Journal of Translational Medicine SP - 336 VL - 16 IS - 1 AB - 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 novel drug candidate, determine appropriate dosing, and document safety and tolerability. SN - 1479-5876 UR - https://doi.org/10.1186/s12967-018-1710-5 DO - 10.1186/s12967-018-1710-5 ID - Karakunnel2018 ER -