PROGETTAZIONE E SVILUPPO DEL FARMACO

Module MODULO 2 FARMACOLOGIA

The course aims to provide fundamental knowledge regarding the principles of drug development. In accordance with the Dublin Descriptors, upon successful completion of the course and the exam, the student will be able to:

*   describe the tests typically conducted during the preclinical screening of a new drug;

*   understand the basic concepts and key elements of the various phases of clinical trials and analyze authorization procedures;

*   comprehend fundamentals of pharmacovigilance and regulatory requirements.

Students must demonstrate critical analysis and evaluation skills regarding the various tests involved in the preclinical trial process and the different phases of clinical trials, and must clearly articulate the knowledge acquired using appropriate technical-scientific terminology.

Face-to-face lectures

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

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

If the course is delivered in blended or remote mode, appropriate adjustments may be made to the above, in order to ensure consistency with the syllabus.

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. 

According to the RDA, Art. 12 – University Educational Credits (CFU): The standard student workload of 25 total hours, corresponding to one credit, may comprise:

a) 7 hours dedicated to lectures or equivalent teaching activities, with the remainder devoted to independent study;

b) between 12 and 15 hours dedicated to classroom exercises or equivalent supervised activities (laboratories), with the remainder devoted to study and personal review.

Clementi, Fumagalli: Farmacologia generale e molecolare

Annunziato, Di Rienzo: Trattato di Farmacologia

The written exam generally consists of four questions: the first focuses on pharmacodynamics, followed by questions on *in vitro* or *in vivo* preclinical testing, methodologies applied to clinical trials, and a description of one of the phases of clinical trials. The average duration of the written exam is one hour. The final grade will be based on the accuracy and coherence of the knowledge demonstrated, the appropriate use of discipline-specific terminology, and the ability to link the topic in question to other related subjects.Passing the exam (with a final grade between 18 and 30) depends on demonstrating knowledge of the essential minimum requirements for the specific topics.Assessment may also be conducted online, should circumstances require it.

INFORMATION FOR STUDENTS WITH DISABILITIES AND/OR SPECIFIC LEARNING DISORDERS (SLD)

To ensure equal opportunities and compliance with current regulations, interested students may request a personal meeting to plan any compensatory and/or dispensatory measures, based on educational objectives and specific needs. Students may contact Prof. Santina Chiechio (santina.chiechio@unict.it), who serves as the CInAP (Center for Active and Participatory Inclusion – Services for Disabilities and/or SLD; https://www.cinap.unict.it/content/referenti) representative for the Department of Drug and Health Sciences.

EXAM DATES

Exam dates are published on the Degree Course website: https://www.dsf.unict.it/it/corsi/lm-13/calendario-esami

EXAM DATES

Exam dates are published on the Department of Drug 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?