07龚兆龙老师—毒代动力学研究在药物安全性评价研究与评估中的应用.pdfVIP

2012年创新药物供试品分析与毒代动力学研究高级培训班 毒代动力学研究在药物安全性评价 研究与评估中的应用 （FDA审评中案例分析） 药代毒代贯穿药物研发全过程 IND (Paper, E-filing ~20GB) NDA (Paper, E-filing ~50GB) CONTENTS OF IND APPLICATION This application contains the following items: (Check all that apply) 1. Form FDA 1571 [21 CFR 312.23(a)(1)] 2. Table of Contents [21 CFR 312.23(a)(2)] 3. Introductory statement [21 CFR 312.23(a)(53)] 4. General Investigational plan [21 CFR 312.23(a)(3)] 5. Investigator’s brochure [21 CFR 312.23(a)(5)] 6. Protocol(s) [21 CFR 312.23(a)(6)] a. Study protocol(s) [21 CFR 312.23(a)(6)] b. Investigator data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 c. Facilities data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 d. Institutional Review Board data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 7. Chemistry, manufacturing, and control data [21 CFR 312.23(a)(7)] Environmental assessment or claim for exclusion [21 CFR 312.23(a)(7)(iv)(e)] 8. Pharmacology and toxicology data [21 CFR 312.23(a)(8)] 9. Previous human experience [21 CFR 312.23(a)(9)] 10. Additional information [21 CFR 312.23(a)(10)] 药物研发药理毒理试验 Chronic Tox (= clinical study duration) Completion of genetic tox battery Carci SX protocols (if needed) Pharmacology Repro Tox Studies Safety Pharm Segs 1, 2, (3) Carcinogenicity Studies Acute/sub-chronic Tox ADME (Seg 3 repro tox) Genetic Tox ADME Integration of all studies FIH, Ph1 Phase 2 Phase 3 NDA *Not shown are Special Tox studies which vary by drug (e.g., pho