作者
Barbara C Sorkin, Adam J Kuszak, Gregory Bloss, Naomi K Fukagawa, Freddie Ann Hoffman, Mahtab Jafari, Bruce Barrett, Paula N Brown, Frederic D Bushman, Steven Casper, Floyd H Chilton, Christopher S Coffey, Mario G Ferruzzi, D Craig Hopp, Mairead Kiely, Daniel Lakens, John B MacMillan, David O Meltzer, Marco Pahor, Jeffrey Paul, Kathleen Pritchett-Corning, Sara K Quinney, Barbara Rehermann, Kenneth DR Setchell, Nisha S Sipes, Jacqueline M Stephens, D Lansing Taylor, Hervé Tiriac, Michael A Walters, Dan Xi, Giovanna Zappalá, Guido F Pauli
发表日期
2020/1
期刊
FASEB journal: official publication of the Federation of American Societies for Experimental Biology
卷号
34
期号
1
页码范围
41
出版商
NIH Public Access
简介
While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a September, 2018 transdisciplinary workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for: NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental …
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BC Sorkin, AJ Kuszak, G Bloss, NK Fukagawa… - FASEB journal: official publication of the Federation of …, 2020