安徽医科大学国际教育学院教案与讲稿 Teaching Plan for International Students,AHMU Title of the course:New drugs development Chapter:One Teacher's name:Associate Prof.Lingling Zhang Grade:2013 Department:Clinical Medicine,School of International Education Time:14:30-16:50 Date(D/M/Y):4/6/2016 1.To master the definition of GCP. Teaching 2.To master the determination of minimum first dose. Objectives; 3.To recognize the purpose and significance Phase II clinical trial. Teaching 4.To recognize the purpose and significance of human bioavailability test. Requirements 5.To know of the definition of drugs,new drug and bioavailability. 6.To know of the components of preclinical drug development. Teaching 1.Preclinical development of new drugs; Content 2.Clinical trial of new drug. Teaching Teaching Focus:The components of preclinical drug development The definition of GCP Focus; Difficult Problems:The determination of minimum first dose.Tolerance test Difficult and pharmacokinetic studies. Problems Solutions:The purpose and significance Phase II clinical trial.The purpose and their and significance of human bioavailability test.The definition of drugs,new Solutions drug and bioavailability; The definition of drugs and new drugs 5 min Preclinical drug development 30min The definition of GCP and the significance of GCP 5min Phase I clinical trial:tolerance test and pharmacokinetic studies 15 min Time Phase II clinical trial is the stage of effect evaluation and safety 40min Allotment Phase III clinical trial 2 min Phase IV clinical trial 3min Drug bioequivalence test 15 min Discuss 5min 1.The definition of drugs 2.The definition of GCP 3.The definition of Bioavailability 4.The components of preclinical drug development Assignment 5.The determination of minimum first dose 6.The purpose and significance Phase II clinical trial 7.The purpose and significance of human bioavailability test 1安徽医科大学国际教育学院教案与讲稿 1 Teaching Plan for International Students, AHMU Title of the course: New drugs development Chapter: One Teacher’s name: Associate Prof. Lingling Zhang Grade: 2013 Department: Clinical Medicine, School of International Education Time: 14:30—16:50 Date (D/M/Y): 4/6/2016 Teaching Objectives; Teaching Requirements 1. To master the definition of GCP. 2. To master the determination of minimum first dose. 3. To recognize the purpose and significance Phase II clinical trial. 4. To recognize the purpose and significance of human bioavailability test. 5. To know of the definition of drugs, new drug and bioavailability. 6. To know of the components of preclinical drug development. Teaching Content 1. Preclinical development of new drugs; 2. Clinical trial of new drug. Teaching Focus; Difficult Problems and their Solutions Teaching Focus: The components of preclinical drug development. The definition of GCP Difficult Problems: The determination of minimum first dose. Tolerance test and pharmacokinetic studies. Solutions: The purpose and significance Phase II clinical trial. The purpose and significance of human bioavailability test. The definition of drugs, new drug and bioavailability; Time Allotment The definition of drugs and new drugs 5 min Preclinical drug development 30 min The definition of GCP and the significance of GCP 5 min Phase Ⅰ clinical trial：tolerance test and pharmacokinetic studies 15 min Phase II clinical trial is the stage of effect evaluation and safety 40min Phase III clinical trial 2 min Phase IV clinical trial 3 min Drug bioequivalence test 15 min Discuss 5 min Assignment 1.The definition of drugs 2.The definition of GCP 3.The definition of Bioavailability 4.The components of preclinical drug development 5.The determination of minimum first dose 6.The purpose and significance Phase II clinical trial 7.The purpose and significance of human bioavailability test