Early-phase clinical trials of anti-HIV drugs-understanding and discussion.
Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical trials. How to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for them. This article references the literature and the experience of reviewers, to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.
LI
YaJie
Y
Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China, liyj@cde.org.cn
ZHAO
Ming
M
ZHAO
DeHeng
D
D019380:Anti-HIV Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D014481:United States
D019380:Anti-HIV Agents