02/19 From bench to bedside and from bedside to bench
02/26 Basic pharmacology for molecular biologists
03/05 Pathophysiology for molecular biologists, how to cure or control disease
03/12 Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion.
03/19 Drug formulation and novel drug delivery systems
03/26 Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human
04/09 Clinical development of new drugs or biologics
04/16 Commercialization of academia achievements in new drug R&D- Taiwan's strategies in regulatory science and project management
04/23 Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human?
04/30 Phase II and phase III clinical studies. Is there any value for the drug to be registered?
05/07 Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance
05/14 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?
05/21 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.
05/28 Case study : Liver cancer treatment
06/04 期末考