The main contents of this international course include the basic knowledge of drug quality standards, techniques on chemical drug analysis, traditional Chinese medicine analysis and biological analysis, and some application cases. The course also introduces basic knowledge of gene testing technique and its application in therapeutic drug monitoring (TDM). Mastering pharmaceutical analysis techniques can provide the necessary professional knowledge and skills for drug research and development, production, clinical use and drug supervision and management. This course is suitable for general higher pharmacy education, pharmacist continuing education, and other multi-level online teaching in pharmacy education area.
Overview
Syllabus
- 1.Drug Quality Standard and Quality Control
- 1.1 Drug Quality Standard
- 1.2 Pharmacopoeia & ICH
- 1.3 Drug Quality Control
- 1.4 Terms for drug quality control
- 2.Pharmaceutical Analysis Methodology
- 2.1 Titrimetry
- 2.2 Neutralization titrition and nonaqueous titrition
- 2.3 Ultraviolet Visible Spectrophotometry
- 2.4 High-performance liquid chromatography and Gas chromatography
- 2.5 Analytical method validation
- 3.Bioanalytical Method
- 3.1 Introduction of biological sample analysis
- 3.2 Preparation and storage of biological samples
- 3.3 Pretreatment-Protein precipitation and liquid-liquid Extraction
- 3.4 Pretreatment-Solid phase extraction and other methods
- 3.5 Bioanalytical method development and validation
- 4.Analytical Methods for Biological Products
- 4.1 Overview of biological product analysis
- 4.2 Procedures for the analysis of biological products
- 4.3 Analysis method of biological products (1)
- 4.4 Analysis method of biological products (2)
- 5.Analytical Methods for Traditional Chinese Medicine
- 5.1 Characteristics of traditional Chinese medicine analysis
- 5.2 Identification of traditional Chinese medicine
- 5.3 Testing items of traditional Chinese medicine analysis
- 5.4 Determination of traditional Chinese medicine analysis
- 6.Genetic Polymorphism Detection Techniques
- 6.1 Real-time fluorescence quantitative PCR technique
- 6.2 Nucleic acid intrusion technique
- 6.3 Biomass spectrometry
- 6.4 Gene chip technology
- 7.Quality Control of Chemical Drugs and Antibiotics
- 7.1 Quality control of Aspirin and its preparations
- 7.2 Quality control of Procaine hydrochloride and its preparations
- 7.3 Quality control of antibiotics
- 7.4 Quality control of penicillin and its preparations
- 8. Drug Clinical Trial Monitoring
- 8.1 Management of drug clinical trial analysis laboratory
- 8.2 Study on human bioavailability and bioequivalence
- 8.3 Therapeutic drug monitoring
- 8.4 Clinical practice of individualized administration of anticoagulant warfarin
- 9. Applications
- Final Examination
Taught by
Wenyuan Liu, Chunyong Wu, Qinxin Song, Min Song, Bo Li, Fang Yan, Qiuling Zheng, and Lingfei Han
