1生物药剂学1.pdf

生物药剂学 上海交通大学药学院 沈 琦 qshen@sjtu.edu.cn Where? Registration Clinical Data Analysis Full Development Studies in 100-300 Patients (Phase II) Candidate Medicine Tested in 3-10,000 Patients (Phase III) Large Amounts of Candidate Medicine Synthesized Extensive Safety Studies Studies in Healthy Candidate Volunteers Phase I Formulations Exploratory Development Developed Early Safety Project Team Studies