103年度研究发展计画appendix a-c - 生技医药国家型科技计画.doc

Appendix A. List of Preclinical Tests (臨床前試驗項目) Please check the box if you plan to perform any preclinical studies on the following list and provide estimated cost for the corresponding tests (please refer to “小額委外試驗項目與費用表” for detailed items and corresponding fees). Please also itemize the budget in “C009-Advanced Instrumentation Usage Fee” (Do not include the cost in the “Consumables”). If this project is funded, NRPB Program Office will assist you in applying for the services. Category Check Here Items of Preclinical Study Budget (in NTD) 一般藥理 篩選試驗 Pharmacological Profiling Tests □ 酵素活性分析 Enzyme Activity Assay □ 受體結合實驗分析 Receptor Binding Assay □ 離體實驗 In Vitro Cell- and Tissue-based Assays □ 活體動物實驗 In Vivo Assays □ 疾病動物模式 Animal Models of Disease □ 安全性藥理實驗 Safety Pharmacology 毒理試驗 Toxicology Study □ 一般/生殖毒理試驗：單一及重複劑量急性、亞急性、慢性毒性試驗、致畸胎性試驗 General/Reproductive Toxicology: Single Dose Toxicology Study, Repeated Dose Toxicology Study (Acute, Subacute, Chronic), Teratology □ 遺傳毒理試驗：基因突變性測試、細胞遺傳毒理測試、小核測試 Genotoxicity Study: Gene Mutation Assays, Cytogenetic Assays, Micronucleus Assays □ 生物相容性試驗：兔子熱源測試法、皮膚敏感性測試、溶血測試、細胞毒性測試 Biocompatibility Studies: Rabbit Pyrogen Test, Intracutaneous Irritation Test in Rabbits, In Vitro Hemolysis in Whole Blood, Cytotoxicity Test 早期藥物 動力學 Early Pharmacokinetic Study □ 藥物吸收試驗 Drug Absorption Study □ 藥物組織分佈試驗 Drug Distribution Study □ 藥物蛋白質結合試驗 Drug Protein Binding Study □ 藥物代謝試驗 Drug Metabolism Study □ 藥物排除試驗 Drug Excretion Study □ 藥物生體可用率試驗及藥物生體相等性試驗 Bioavailability and Bioequivalence Study □ 檢體分析 Bioanalysis □ 毒性動力學 Toxicokinetic Study □ 動物藥物動力學及藥效學試驗 In Vivo Pharmacokinetic Study and Pharmacodynamic Study Appendix . List of NRPB Resource Center/NCFPB Core Facility (資源中心/生技類核心設施列表) Please refer to the following list and check the box if you intend to use any of the services from NRPB Resource Center or NCFPB Core Facility. If you check any of the boxes, do discuss with the PIs/managers