03/03From bench to bedside and from bedside to bench
03/10Pathophysiology for molecular biologists, how to cure or control disease
03/17Basic pharmacology for molecular biologists
03/24Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion.
03/31Drug formulation and novel drug delivery systems
04/07Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human
04/14Clinical development of new drugs or biologics
04/21Regulations and international standards for drug development, GMP, GLP, GCP etc.
04/28Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human?
05/05Phase II and phase III clinical studies. Is there any value for the drug to be registered?
05/12Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance
05/19Biostatistics 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?
05/26Non-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.
06/02Medical imaging studies to guide drug development
06/09Case study : anticancer drug development
06/16Case study : Liver cancer treatment
06/23期末考