审查
人类疾病
临床试验
模式
医学
选择(遗传算法)
药物开发
计算机科学
药理学
计算生物学
疾病
生物
药品
政治学
病理
人工智能
法学
社会学
社会科学
作者
Jay Tibbitts,Joy A. Cavagnaro,Christine Haller,B. J. Marafino,Paul A. Andrews,John T. Sullivan
标识
DOI:10.1016/j.yrtph.2010.06.007
摘要
Recent advances in our understanding of disease biology, biomarkers, new therapeutic targets, and innovative modalities have each fueled a dramatic expansion in the development of novel human therapeutics. Many are biotechnology-derived biologics possessing high selectivity and affinity for their intended target; as such they often pose challenges in the development path to approval. One challenge is the selection of the first-in-human (FIH) dose. This process has come under increased scrutiny as a result of a FIH trial with a super-agonist monoclonal antibody (TGN1412), which resulted in significant injury to healthy volunteers. Regulatory agencies have responded with supplemental guidance for the development of novel therapeutics. The intent of this paper is to provide experience-based insight, with relevant examples, for those planning the first administration of novel biopharmaceuticals in humans.
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