三、研究计画内容.docVIP

三、研究計畫內容 Please follow the requirements below: Type setting: Times New Roman, Arial or Calibri, 12-point, single-spaced Page limit for Item 2-7: 18 pages 藥物開發概況表 (請依申請案之開發階段，選擇合適之表格，並參考表格中之撰寫重點填寫；請刪除不需要之表格或說明，並視需要自行調整欄寬) 請問此申請案屬於： □ Candidate-to-IND；曾獲NRPB補助執行之計畫編號和計畫名稱: ________________________ □ 新穎/優化小分子藥物 □ First-in-Class (new drug target) □ Me-Better (known drug target) 如為「新穎/優化小分子藥物」，是否已知drug target之蛋白質結構，以助於闡明化合物與標的蛋白質分子間交互作用assay □ 已進行hit validation，已獲得_____個經確效的hits □ 已進行lead identification，已獲得_____個經確效的leads Candidate-to-IND Item Current Status Product Description Type of Agent (small molecule, peptide, mAb, etc.) Drug Target Profile Indication and Usage Clinical Indication(s) (if more than one, specify intended lead indication) Intended Patient Population Clinical Development Plan Development Candidate Preclinical Work Target Specificity Efficacy (in vitro, cell-based, and in vivo) Animal Model(s) of Disease Safety/Toxicity Profiles Clinical Pharmacology Absorption, Distribution, Metabolism, Excretion Half-Life in Plasma or Serum Pharmacological Duration of Effect (extent of target inhibition or activation) Protein Binding, etc. Dosage and Administration Dosing Amount, Route, Frequency, etc. Formulation (excipients) Safety and Toxicity in Humans Known On-target or Off-target Predicted Safety Concerns Desired/Achievable Therapeutic Window Intellectual Property Desired Licensing Outcome (license to company vs. start-up) First-in-Class (new drug target) / Me-Better (known drug target) Item Description Drug Target Background and Rationale Drug Target validation (structural, pharmacological and/or genetic) Currently available tool compound* for the drug target Compound(s) Description Indication and Usage Clinical Indication(s) Intended Patient Population Competitive Landscape High throughput Screening (HTS) Readiness and Plan (For First-in-Class only; HTS to hit validation should be finished in 5 months) HTS assay description Charact