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工業技術研究院

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技術名稱: 植物新藥技術平台

技術簡介

植物新藥開發技術平台(專利:7案34件, 技資報告: 29件)

Abstract

Botanical new drug development platform technology (Patents: 7 cases 34 items, Reports: 29 items)

技術規格

植物新藥開發技術文件套件,包括藥材、原料藥、與成品的 規格、非臨床毒理與安全藥理評估、藥效評估、與臨床試驗 設計

Technical Specification

Botanical new drug development package, including specifications of botanical raw material, drug substance, and drug product, non- clinical tox/safety pharmacology studies, pharmacodynamics studies, and clinical study protocol

技術特色

依據美國FDA Botanical Drug Product Guidance (2004)所進行的植物新藥開發

應用範圍

治療與預防

接受技術者具備基礎建議(設備)

植物新藥開發相關實驗室與GMP試驗工廠(含委託對象的設 備/設施)

接受技術者具備基礎建議(專業)

植物新藥開發與臨床試驗申請能力與經驗

技術分類 醫藥技術

聯絡資訊

聯絡人:楊雅燕 標靶藥物技術中心

電話:+8863574-3943 或 Email:violet@itri.org.tw

客服專線:+886-800-45-8899

傳真:+8863573-2373

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