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Early-phase clinical trials of anti-HIV drugs—understanding and discussion

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Abstract

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.

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Authors and Affiliations

  1. Center for Drug Evaluation, State Food and Drug Administration, Beijing, 100038, China

    YaJie Li, Ming Zhao & DeHeng Zhao

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  1. YaJie Li
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  2. Ming Zhao
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  3. DeHeng Zhao
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Correspondence to YaJie Li.

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Li, Y., Zhao, M. & Zhao, D. Early-phase clinical trials of anti-HIV drugs—understanding and discussion. SCI CHINA SER C 52, 521–527 (2009). https://doi.org/10.1007/s11427-009-0073-9

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