The aim of the course is to provide professionals working in or involved with the pharmaceutical and biopharmaceutical innovation industry a basic but broad overview of issues related to pharmaceutical research, new drug development and the regulatory framework.
Specifically, after completion of this course the student should be able to:
1) Incorporate the basic principles of pharmacology, pharmacokinetics and biostatistics in the drug development process, intended to ensure the required levels of safety and efficacy.
2) Be able to plan, prepare and submit a comprehensive proposal to develop a new drug (original or generic), including IND and NDA license applications.
3) Be able to identify and solve practical, theoretical and technical problems associated with preclinical and clinical drug trials (including post-marketing surveillance and environmental risk assessment).
4) Be able to understand the function of and be able to communicate and interact with national and international authorities that control the conduct of drug trials and issuing or amending authorization of medicines (original and generic).
5) Know and be able to critically analyze all stages of new drug development (original or generic).
Course Content (Syllabus)
Non clinical drug development
Design of clinical drug development programs
Dose response and concentration response analysis
Animal scale up and Phase I studies
Disease progression models and clinical trial simulation
Physiological and laboratory markers of drug effect/Quality assessment of drug therapy
Post-marketing Surveillance Studies
GLP/GCP requirements in drug development
Environmental risk assessment
Drug development for special populations
Development of biotechnology products and large molecules
Development and applications of cell based therapies
Role of the FDA/EMEA in guiding drug development
Pharmaceutical Research, Drug Development, Preclinical trials, Clinical trials, Post-marketing surveillance, Environmental risk assessment, Biomarkers, GLP/GCP
Course Bibliography (Eudoxus)
1) Designing Clinical Research, 2013, 4th Edition, Stephen B. Hulley, Steven Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman
2) Design & Analysis of Clinical Trials, 2013, 3rd Edition, Shein-Chung Chow, Jen-Pei Liu