Ross Jennifer J, Boucher Philip E, Bhattacharyya Siba P, Kopecko Dennis J, Sutkowski Elizabeth M, Rohan Patricia J, Chandler Donna K F, Vaillancourt Julienne
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration/PHS, Rockville, MD, USA.
Curr Issues Mol Biol. 2008;10(1-2):13-6.
Food products in the United States (U.S.), including dietary supplements, may contain live microorganisms and can be promoted for general health, nutritional, or structure/function claims. In contrast, such preparations used with the intention of having a preventive or therapeutic effect in humans are regulated by the Food and Drug Administration (FDA) in the U.S. as biological products, specifically as live biotherapeutic products (LBPs). Discussion of considerations in the early development of LBPs may aid in preparation of an Investigational New Drug Application (IND) that is designed to collect clinical data to support marketing approval of a LBP in the U.S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study.
美国的食品，包括膳食补充剂，可能含有活的微生物，并可因一般健康、营养或结构/功能宣称而得到推广。相比之下，旨在对人类产生预防或治疗作用而使用的此类制剂在美国被食品药品监督管理局（FDA）作为生物制品进行监管，具体而言作为活生物治疗产品（LBP）。讨论LBP早期开发中的注意事项可能有助于准备一份研究性新药申请（IND），该申请旨在收集临床数据以支持LBP在美国针对特定临床用途的上市批准。产品信息是支持拟议临床研究的IND的重要组成部分。
