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| 題 名 | The Exploratory IND (Phase 0) Concept=試探性新藥臨床研究(Exploratory IND或階段零臨床試驗)的概念 |
|---|---|
| 作 者 | 洪家瑤; | 書刊名 | 核子醫學雜誌 |
| 卷 期 | 22:2 2009.06[民98.06] |
| 頁 次 | 頁93-100 |
| 分類號 | 418 |
| 關鍵詞 | 試探性新藥臨床研究; 階段零臨床試驗; 美國食品暨藥物管理局; 微劑量; Exploratory IND; Phase 0 clinical trials; FDA; Microdosing; |
| 語 文 | 英文(English) |
| 中文摘要 | 近年來藥品的研發費用仍不斷攀升,雖然新科技的介入已大幅加速新藥的研究發展過程。美國食品暨藥物管理局(FDA)爲了幫助藥品的研發,主動發佈試探性新藥臨床研究(Exploratory IND)(或階段零臨床試驗)指引,作爲提供新藥研發非常早期臨床研究的依據。微劑量(microdose)爲Exploratory IND在新藥研發初期收集人體藥物動力學及藥效學數據的主要工具。由於微劑量的設計不會引起任何藥理效應,Exploratory IND的研究對受試者是安全的。這種微劑量的研究可以由較少數的臨床前安全研究開始,對於篩選有希望進一步評估的新藥,可以減少資源與時間的需求。 |
| 英文摘要 | In recent years, the costs for drug research and development (R&D) have escalated despite the fact that new technology is evolving and has greatly accelerated the R&D process for new drugs. To aid in the drug R&D process, FDA, as part of their critical path initiative, released a guidance for Exploratory IND studies (or Phase 0 clinical trials) which are intended to provide clinical information for a new drug candidate at a much earlier phase of drug R&D process. Microdose is a primary tool in exploratory IND to allow the collection of human pharmacokinetic and pharmacodynamic data earlier in the drug R&D process. Since microdosing approach is designed not to induce any pharmacological effects, these studies are safe to the participating human subjects. Microdosing studies also can be initiated with fewer preclinical safety studies, as well as require lesser resources and time for selecting promising drug candidates for further evaluation. |
本系統中英文摘要資訊取自各篇刊載內容。