GLP-workshop非临床毒性测试及查核重点(二)-非临床毒性测试SD扮演之角色-张羢悌.pdf

GLP WORKSHOP 非臨床毒性測試及查核重點 非臨床毒性測試 STUDY DIRECTOR 扮演之角色 張羢悌 Nov. 06, 2012 台灣生醫品質保證協會理事 前昌達生化科技股份有限公司毒理與臨床前測試中心試驗主持人 JTC, Nov. 06, 2012 1 Investigational New Drug (IND) Application Package  Background Information of IND  Objectives and Program of Clinical Trial  Investigator’s Brochure  Clinical Protocol  Chemical, Manufacturing and Control Info.  Pharmacology  Toxicology and Pharmacokinetics JTC, Nov. 06, 2012 2 Pre-clinical Safety Study ICH M3 (R2): Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals Purposes  Estimate an initial safe starting dose and dose range for the human trials  Identify parameters for clinical monitoring for potential adverse effects Study design  Characterize of toxic effects with respect to target organs, dose dependence, relationship to exposure, and appropriate, potential reversibility JTC, Nov. 06, 2012 3 行政院衛生署藥品非臨床試驗安全性規範 非臨床試驗的目的  決定人體臨床試驗的安全起始給與劑量及劑量 增加之方式 測定試驗物質在標的器官中引起的毒性與其可 逆性  決定臨床試驗的觀察檢測參數 所有毒性試驗均需依循 GLP規範進行，作為 產品安全性評估時之依據 JTC, Nov. 06, 2012 4 行政院衛生署藥品非臨床試驗安全性規範 毒性試驗規範  單一劑量毒性試驗 (Single Dose Toxicity Study)  重覆劑量毒性試驗 (Repeated Dose Toxicity Study)  基因毒性試驗 (Genotoxicity Study)  生殖與發育毒性試驗 (Reproductive and Development Toxicity Study)  致癌性試驗 (Carcinogenicity Study)  皮膚過敏性試驗 (Skin Sensitization Study)  皮膚感光過敏性試驗 (Skin Photosensitization Study)  皮膚刺激性試驗 (Skin Irritation S