PROGETTAZIONE E SVILUPPO DEL FARMACO

Module MODULO 2 FARMACOLOGIA

At the end of the course, to pass the exam, the student must demonstrate that he/she has acquired:

• the terminology and basic concepts related to the tests normally performed in the preclinical screening of a new drug.

• the basic concepts and key words of the different phases of the clinical trial of a drug.

According to what is reported in the RDA, Art. 12 - University Training Credits (CFU), the standard load of 25 hours of overall student commitment, corresponding to one credit, can include: 7 hours dedicated to lectures or equivalent teaching activities and the remainder to individual study

If the teaching is given in a mixed or remote mode, the necessary variations with respect to what was previously stated may be introduced, in order to respect the program envisaged and reported in the syllabus

Information for students with disabilities and / or SLD: To guarantee equal opportunities and in compliance with the laws in force, interested students can ask for a personal interview in order to plan any compensatory and / or dispensatory measures, based on the teaching objectives and specifications needs. It is also possible to contact the CInAP contact person (Center for Active and Participatory Integration - Services for Disabilities and / or SLD) of the DEPARTMENT OF DRUG AND HEALTH SCIENCES,Prof.ssa Santina Chiechio

Program

Preclinical studies: (2 cfu):

 • Biochemical and physiological effects of a drug and molecular mechanisms through which these effects are produced (pharmacodynamics)

• In vitro and in vivo studies for the pharmacological characterization of a drug

• Concept of selectivity, affinity, efficacy and potency of a drug

• Principles of acute and chronic toxicity

• Absorption, distribution in organs, tissues and cells, metabolic transformations and pathways and methods of elimination of a drug

• Methodologies for the pharmacokinetic characterization of a drug

Clinical trials (1cfu):

• General principles and purposes of clinical trials

• Rules of good clinical practice

• Clinical research protocols

• Phases of clinical trials

• The actors of clinical trials: participants, sponsors, contract research organizations and regulatory agencies. Ethics committees, protocol and informed consent. 

Clementi, Fumagalli: Farmacologia generale e molecolare

Annunziato, Di Rienzo: Trattato di Farmacologia

Exam dates are published on the Department of Pharmaceutical and Health Sciences website:https://www.dsf.unict.it/sites/default/files/CALENDARIO%20ESAMI%20CDLM%20FARMACIA%202025%20%2B.pdf

How are preclinical studies related to ADME conducted?

Who is the Ethics Committee composed of and what are its functions?

How are Phase I clinical studies conducted?

What is a bias?