General guidance regarding analytical procedures and methods validation information to be submitted for phase 2 or phase 3 studies will be provided in the FDA guidance for industry INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufac...
In general, the recommended phase 2 dose (RP2D) has been established for an investigational drug or drugs evaluated in a master protocol. This guidance is intended to serve as advice and a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the ...
临床研究产品和获批产品（包括生物制品）的生产必须符合FD&C法案规定的cGMP要求。比如I期临床样品应符合“CGMP for Phase 1 Investigational Drugs: Guidance for Industry,” July 2008的要求，II期及以后应符合21 CFR part 210 & 211的cGMP要求。BLA必须包含证明产品符合安全性，纯度和效价要求的数据，生产方法的完整...
The U.S. Food and Drug Administration (FDA) inspectedyour drug manufacturing facilities: Lupin Limited at 15-B, Phase 1A, VernaIndustrial Area, Verna, Salcette, Goa from March 27 to April 7, 2017 (“LupinGoa”) and Lupin Limited at Unit 2–Plot No. 2, ...
• 基因编辑组件的生产要求需要根据临床研究满足适当的cGMP原则。1期临床对cGMP的要求可以参考“FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs“，2期临床及以后需要完全符合cGMP条件；• 基因编辑组件需要根据生产制定质量标准，标准中要对其安全项、鉴别、纯度、活性、残留进行规定。尤其是...
Please follow CDISC guidance for terminology. The variable EPOCH should be included for clinical subject-level observation (e.g., adverse events, laboratory, concomitant medications, exposure, and vital signs). This will allow the reviewer to easily determine during which phase of the study the ...
制造商等)的IND amendment,监管机构建议申请人包括一份“审阅者指引”(Reviewer’s Guide)如FDAeCTD技术合规指南《Technical Specifications Document》中所述,或一份列出所有变更的跟踪文件,并且建议申请人给予足够的时间(例如30天)供FDA在新批次临床试验材料放行前进行审查,具体参考《CMC GT INDs Guidance》【Reference...
II. GUIDANCE (2) A. Drug Substance (2.1) 1. General (2.1.1) Information on the stability of the drug substance is an integral part of the systematic approach to stability evaluation. 2. Stress Testing (2.1.2) Stress testing of the drug substance can help identify the likely degradation ...
遗传毒性实验一般Phase Ⅱ前：体外+体内标准组合(Core battery)；而对于抗肿瘤药物IND阶段不是必须的。生殖毒性实验，根据现行指南，Initial IND中美申报时可不提供生殖毒性试验相关内容；进入Ⅱ期临床时：Seg Ⅱ生殖毒性的预试验，进入Ⅲ期临床时：完成Ⅰ段生殖毒性和两种动物种属的Ⅱ段生殖毒性正式试验；NDA前完成围产...
FDA与发起人的会议分为四种:属于早期协商阶段的IND前会议(pre-IND meetings)和Ⅰ期结束会议(End-of-phase 1 meetings);以及属于临床试验阶段的Ⅱ期结束会议(End-of-Phase 2 meetings)和新药申请前会议(Pre-NDA meetings)或生物制品许可申请前会议(Pre-BLA meetings)。发起人可以请求的正式会议类型有三种:类型A、...