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.

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

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?