FDA Guidance documents relevant to Pharmacology and Toxicology information are available and describe ways in which requirements related to conduct of non-clinical toxicology studies may be met. In addition to description of the...
此外,还有各种指导文件(guidance documents)和标准操作程序(standard operating procedures)来明确IND流程的政策和程序。 05 常见问题(FAQ) (1)问:何时需要提交IND申请? 答:当申办者打算开展一项涉及对人体施用研究性产品的临床研究,且该研究未获得...
FDA Guidance documents relevant to Pharmacology and Toxicology information are available and describe ways in which requirements related to conduct of non-clinical toxicology studies may be met. In addition to description of the results of each study, the IND sponsor is required to include the identi...
此外,还有各种指导文件(guidance documents)和标准操作程序(standard operating procedures)来明确IND流程的政策和程序。 05 常见问题(FAQ) (1)问:何时需要提交IND申请? 答:当申办者打算开展一项涉及对人体施用研究性产品的临床研究,且该研究未获得IND要求的豁免时,必须提交IND申请。除非获得豁免,否则申办者必须通过提交...
Before submitting an IND application, investigators should refer to the Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB) to determine whether their clinical in...
编写IND申请:IND申请包括详细的研究计划、药物化学信息、非临床数据、临床试验设计、研究人员背景等内容。申请文件应该遵循FDA的要求和指导文件,包括《新药临床试验指导原则》(Guidance for Industry - Investigational New Drug Applications (INDs))。 提交申请:将完整的IND申请文件提交给FDA。申请文件的提交方式可以是电子...
The document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND, and describes the procedure, organization structure, and practices for safety assessment of IND ...
非商业性IND是由医生自行开展的研究,该研究旨在研究药品对特定人群的疗效或为无药可治的患者提供未经批准的药物治疗。非商业性IND包括有研究性IND(Investigator IND/Research IND)。 《联邦法律汇编》第21篇章分册 2. 新药申请(New Drug Application,NDA)/生物制剂上市许可申请(Biologics License Applications,BLA) ...
此次修订旨在确保这些非IND的境外临床研究遵循良好临床实践（GCP）标准，包括独立伦理委员会（IEC）的审核和批准，以及受试者的知情同意。2012年3月，FDA发布了指南《Guidance for Industry: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions》，旨在帮助申办方理解如何...
美国FDA 指导原则 INDS(研究性新药应用)和BA BE(生物利用度生物等效性)研究的安全报告要求 英文原版.pdf,Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies U.S. Department of Health and Human Services Food and Drug