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Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium Difficile Infection Not Responsive to Standard Therapies.

机译：行业指南：关于使用粪便微生物群移植治疗艰难梭菌感染的研究新药要求的执行政策不符合标准疗法。

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Fecal microbiota collected from healthy individuals are being investigated for use in the treatment of C. difficile infection. Published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy and safety profiles of this intervention have not yet been fully evaluated in controlled clinical trials.

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年度 2013
页码 1-4
总页数 4
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Industry guidance; Drugs; Feces; Transplantation; Clostridium; Clinical trials; Infectious diseases; Intestines; Investigations; Microbiota; Risk; Safety; Therapy; Fecal microbiota; Clostridium difficile infection;

机译：行业指南;药物;粪便;移植;梭菌;临床试验;传染病;肠;研究;微生物群;风险;安全性;治疗;粪便微生物群;艰难梭菌感染;

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1. What is the value of a food and drug administration investigational new drug application for fecal microbiota transplantation to treat clostridium difficile infection? [J] . HechtG.A., BlaserM.J., GordonJ., Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association . 2014,第2期

机译：食品和药物管理局正在研究的新药在粪便菌群移植中治疗艰难梭菌感染的价值是什么？
2. Treating Clostridium difficile infections: Should fecal microbiota transplantation be reclassified from investigational drug to human tissue? [J] . Mark Stuntz, Franka des Vignes Contemporary Clinical Trials Communications . 2015,第2期

机译：治疗艰难梭菌感染：粪便菌群移植是否应从研究药物重新分类为人体组织？
3. Tacrolimus concentration to dose ratio in solid organ transplant patients treated with fecal microbiota transplantation for recurrent Clostridium difficile Clostridium difficile infection [J] . Woodworth Michael H., Kraft Colleen S., Meredith Erika J., Transplant infectious disease: an official journal of the Transplantation Society . 2018,第2期

机译：用粪便微生物腹膜移植治疗复发性梭菌梭菌性梭菌感染治疗固体器官移植患者剂量比的Tacrolimus浓度
4. The Efficacy of Fecal Microbiota Transplantation in Elderly Patients with Clostridium Difficile Infection [D] . Lee, Dayeun 2019

机译：粪便微生物群移植在老年腹菌感染患者中的疗效
5. Treating Clostridium difficile infections: Should fecal microbiota transplantation be reclassified from investigational drug to human tissue? [O] . Mark Stuntz, Franka des Vignes 2015

机译：治疗艰难梭菌感染：是否应将粪便菌群移植从研究药物重新分类为人体组织？
6. Treating Clostridium difficile infections: Should fecal microbiota transplantation be reclassified from investigational drug to human tissue? [O] . Mark Stuntz, Franka des Vignes 2015

机译：治疗艰难梭菌感染：粪便微生物群移植是否应该从研究药物重新分类到人体组织？

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Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium Difficile Infection Not Responsive to Standard Therapies.

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