New drugs development 新药研发 Professor Lingling Zhang(张玲玲) Institute of clinical pharmacology,AHMU 安徽医科大学临床药理研究所) Izhang@ahmu.edu.cn
New drugs development 新药研发 Professor Lingling Zhang (张玲玲 ） Institute of clinical pharmacology, AHMU (安徽医科大学临床药理研究所 ) llzhang@ahmu.edu.cn
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 2
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. 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
Aims 1.To know of: (1)The definition of drugs,new drug and bioavailability. (2)The components of preclinical drug development. 2.To master (1)The definition of GCP. (2)The determination of minimum first dose. (3)The purpose and significance Phase II clinical trial. (4)The purpose and significance of human bioavailability test. 2019/8/28 Institute of clinical pharmacology,AHMU 3
Aims 1. To know of : (1) The definition of drugs, new drug and bioavailability. (2) The components of preclinical drug development. 2. To master : (1) The definition of GCP . 2019/8/28 Institute of clinical pharmacology, AHMU 3 (2) The determination of minimum first dose. (3) The purpose and significance Phase II clinical trial. (4) The purpose and significance of human bioavailability test
A example: Headache Drug Alleviation Question:What's drug? 2019/8/28 Institute of clinical pharmacology,AHMU 4
A example: Headache Drug Alleviation 2019/8/28 Institute of clinical pharmacology, AHMU 4 Headache Drug Alleviation Question: What’s drug?
The definition of drugs and new drugs 1.Drugs:drugs are some materials,which are used for the prevention,treatment and diagnosis of diseases,regulating physiological function,and having indications,major functions and usage. 2019/8/28 Institute of clinical pharmacology,AHMU 5
The definition of drugs and new drugs 1.Drugs: drugs are some materials, which are used for the prevention, treatment and diagnosis of diseases, regulating physiological function, and having indications, major functions and usage. 2019/8/28 Institute of clinical pharmacology, AHMU 5