At completion of the course, students must be able to: a) describe the scientific, health-related and economic factors involved in drug discovery and development; b) describe strategies currently used for drug discovery; c) describe regulatory requirements for pre-clinical and clinical development; d) describe ethical aspects related to drug development; e) describe the requirements, methodology and procedures used in preclinical drug development; f) describe the requirements, methodology and procedures used in the four phases of clinical development; g) interpret critically methodology and results of clinical trials; h) design rationally studies for drug evaluation
Course Prerequisites
In order to be able to adequately address the drug discovery and development course and thus to undergo the examination, it is appropriate to have foundational knowledge from the initial years of the degree program, with particular reference to principles of chemistry, biology, anatomy and physiology.
Teaching Methods
The course includes formal and interactive lectures. Faculty members are available at times reserved for student visits to provide clarifications about topics included in the course.
Assessment Methods
The examination consists in multiple choice questions (KIRO platform) addressing the topics included in the course. Students need to demonstrate that they achieved the learning objectives of the course.
Texts
Hill RG, Rang HP, Drug Discovery and Development, 2nd Edition, Churchill Livingstone, 2012 Ng R, Drugs: from Discovery to Approval, third edition, Wiley, 2015 Blass BE, Basic Principles of Drug Discovery and Approval, Associated Press, 2015
Contents
The topics addressed in the course include: scientific, health-related and economic forces driving drug discovery and development; different strategies used for drug discovery; procedures for selection of leading candidates compounds; regulatory aspects covering drug development; ethics in drug development, including those related to the use of placebo and sub-optimal controls; in vitro and in vivo testing for screening candidate compounds; methods used to determine general and special pharmacology and preclinical toxicology; the 4 phases of drug development; methodology for clinical drug assessment with special reference to the limitations of uncontrolled trials and the methodological aspects of randomized controlled trials; seeding trials, interpretative pitfalls in assessing clinical trials, repurposing of approved medications; ghost authorship and publication bias in drug studies.
