(a)(5)]: Under the auspices of the International Conference on Harmonization (ICH), a document that provides general guidance on the Investigator's Brochure has been developed and will soon be published in the Federal Register (Good Clinical Practice: Guideline for the Investigator's Brochure)....
Principal investigator 主要研究者 CI: Co-inveatigator 合作研究者 SI :Sub-investigator 助理研究者 COI :Coordinating investigtor 协调研究者 DGMP: 医疗器械生产质量管理规范 ICF: Informed consent form 知情同意书 RCT : randomized controlled trial, 随机对照试验 NRCCT: non-randomized concurrent controlled ...
In addition, the handy “informational sheets” that some nutritional supplement or “neutraceutical” dealers keep under the counter at their stores and are given out to answer question from consumers also meet FDA’s definition of labeling. So when they hand you an informational brochure saying...
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be...
(a)(5)]: Under the auspices of the International Conference on Harmonization (ICH), a document that provides general guidance on the Investigator's Brochure has been developed and will soon be published in the Federal Register (Good Clinical Practice: Guideline for the Investigator's Brochure)....
需要金币:*** 金币(10金币=人民币1元) 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 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies...
accelerated approval:加速批准 standard drug:标准药物 investigator :研究人员;调研人员 preparing and submitting:起草和申报 submission:申报;递交 benefit(s):受益 risk(s):受害 drug product:药物产品 drug substance:原料药 established name:确定的名称 generic name:非专利名称 proprietary name:专有名称; INN(...