週次 |
日期 |
單元主題 |
第1週 |
3/03 |
Pathophysiology for molecular biologists, how to cure or control disease |
第2週 |
3/10 |
From bench to bedside and from bedside to bench |
第3週 |
3/17 |
Basic pharmacology for molecular biologists |
第4週 |
3/24 |
Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion |
第5週 |
3/31 |
Drug formulation and novel drug delivery systems |
第6週 |
4/07 |
Clinical development of new drugs or biologics |
第7週 |
4/14 |
Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human |
第8週 |
4/21 |
Phase II and phase III clinical studies. Is there any value for the drug to be registered? |
第9週 |
4/28 |
Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human? |
第10週 |
5/05 |
Commercialization of academia achievements in new drug R&D- Taiwan's strategies in regulatory science and project management |
第11週 |
5/12 |
Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance |
第12週 |
5/19 |
Biostatistics in clinical trials. What is the probability that the drug effect we show in the clinical trial is true? What is the effect size of the treatment? |
第13週 |
5/26 |
Non-interventional clinical research and development of biomarkers. Prediction or prognosis. Ethical issues to conduct a clinical research. Standardization, validation, registration and certification of the tests |
第14週 |
6/02 |
Case study : Liver cancer treatment |
第15週 |
6/09 |
Immunology, basic and clinical immunology |
第16週 |
6/16 |
Cancer biology and cancer clinical trials |
第17週 |
6/23 |
期末考 |