週次 |
日期 |
單元主題 |
第1週 |
2/23 |
From bench to bedside and from bedside to bench (楊志新) |
第2週 |
3/02 |
Commercialization of academia achievements in new drug R&D- Taiwan's strategies in regulatory science and project management (陳恆德) |
第3週 |
3/09 |
Basic pharmacology for molecular biologists (林滿玉) |
第4週 |
3/16 |
Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion. (林君榮) |
第5週 |
3/23 |
Pathophysiology for molecular biologists, how to cure or control disease (楊志新) |
第6週 |
3/30 |
Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human (林滿玉) |
第7週 |
4/06 |
溫書假 |
第8週 |
4/13 |
Clinical development of new drugs or biologics (許駿) |
第9週 |
4/20 |
Drug formulation and novel drug delivery systems (沈麗娟) |
第10週 |
4/27 |
Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human? (林家齊) |
第11週 |
5/04 |
Phase II and phase III clinical studies. Is there any value for the drug to be registered? (徐志宏) |
第12週 |
5/11 |
Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance (高純琇) |
第13週 |
5/18 |
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? (簡國龍) |
第14週 |
5/25 |
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. (俞松良) |
第15週 |
6/01 |
Case study: Liver cancer treatment (徐志宏) |
第16週 |
6/08 |
Cancer biology and cancer clinical trials (林季宏) |
第17週 |
6/15 |
Immunology, basic and clinical immunology (許秉寧) |
第18週 |
6/22 |
期末考 |