Outlines I.Preclinical development of new drugs; II.Clinical trial of new drugs: 1.GCP and the significance of implementing GCP. 2.International Council for Harmonization,ICH 3.Phase I clinical trial tolerance test and pharmacokinetic studies. 4.Phase II clinical trial. 5.Phase III clinical trial. 6.Phase IV clinical trial. 7.Drug bioequivalence test. III.Drug consistency evaluation 2019/8/28 Institute of clinical pharmacology,AHMU 2Outlines I. Preclinical development of new drugs; II. Clinical trial of new drugs: 1.GCP and the significance of implementing GCP. 2. International Council for Harmonization, ICH 3. PhaseⅠ clinical trial ： tolerance test and pharmacokinetic studies. 2019/8/28 Institute of clinical pharmacology, AHMU 2 4. Phase II clinical trial. 5. Phase III clinical trial. 6. Phase IV clinical trial. 7. Drug bioequivalence test. III. Drug consistency evaluation