Degree course: 
Corso di First cycle degree in BIOTECHNOLOGY
Academic year when starting the degree: 
Academic year in which the course will be held: 
Course type: 
Compulsory subjects, characteristic of the class
Second semester
Standard lectures hours: 
Detail of lecture’s hours: 
Lesson (48 hours)

To fully understand the topics addressed in the present course, studens should possess basic notions of cellular biology and general physiology.

Final Examination: 

Approximately halfway through the course, students will undergo an in itinere evaluation (about 60 minutes in duration) based on 10 multiple choice quizzes on topics addressed during the lectures (students shall explain the reason for their choice). Each correct answer will earn 1 point, provided it is adequately explained; a correct answer without an adequate explanation will earn 0 points; a wrong answer will earn a negative (-1) point. The resulting score will amount to one third of the final grade *; the remaining two thirds of the final grade will be earned by an oral interview (about 20 minutes in duration), involving:
(a) one question assessing the knowledge and comprehension of the molecular and cellular aspects of drug action (0- 6 points);
(b) one question assessing the knowledge and comprehension if the principles of pharmacokinetics and pharmacogenetics, of the differences between biological and conventional drugs, of the prospective applications of nanotechnologies and cell therapies to drug delivery, and of the issues involved in the development of new drugs (0-6 points);
(c) one exercise based on the interpretation of dose (or concentration)/response curves or binding isotherms to asses the students' ability to apply theoretical concepts to the analysis of quantitative data (0-6 points).

The remaining 2 points, and possible honors, will be awarded based on the students' ability to connect, communicate and discuss the topics addressed by the questions and exercise described above.

* In case of a negative outcome of the in itinere evaluation, students can refuse it; in this case the oral interview will include two additional questions, one for type (a) and one for type (b); each question will earn a maximum of 5 points. This procedure will also apply in case a student is unable to undergo the in itinere evaluation.

Voto Finale

The course will provide students with theoretical principles and the basic tools required to:
1. understand the interactions between drugs and their molecular targets and predict their effects on cells, tissues and on the whole organism (principles of pharmacodynamics);
2. understand the modifications that drugs undergo once they enter the organism (principles of pharmacokinetics) and the possible interactions with other drugs;
3. understand the genetic bases for individual variability in drug responses (principles of pharmacogenetics).
The course will also focus on biologic drugs, emphasizing the differences from conventional agents; on novel drug delivery nanotechnologies and on gene-based and cell-based therapies.
Finally, the different phases of the pre-clinical and clinical development of new drugs will be described, to provide the student with a picture of the pathway and pitfalls of drug transfer from bench to bedside.

Knowledge and understanding
At the end of the course, students should be able to:
1. understand and describe the bases for drug interactions with organs and systems;
2. understand and discuss the principles and the molecular and cellular mechanisms that characterize drug interactions with their targets, including receptors, ion channels, membrane transporters, enzymes and nucleic acids;
3. understand and discuss the general principles of pharmacokinetics and pharmacodynamics;
4. understand and discuss the relevance and features of novel biological agents, drug delivery systems and therapeutic approaches
5. be familiar with the major phases in drug development and be aware of the related ethical and economical issues.

Applying knowledge and understanding
At the end of the course, students should be able to analyze drug-receptor interactions from a qualitative and quantitative standpoint and to interpret the relationships between the dose (or concentration) of a drug and the corresponding elicited effect.

1. Introduction to Pharmacology: general concepts and historical background. Phases in the drug development process.
2. Drug absorption, distribution, metabolism and excretion (ADME); drug interactions
3. Principles of pharmacogenetics
4. Qualitative and quantitative aspects of drug-receptor interactions
5. Molecular mechanisms of drug action (drug targets, classes of receptors, ion channels, enzmes and membrane transporters).
6. Pharmacological modulation of cell function: second messengers and post-translational modifications
7. Nucleic acids as drug targets and as pharmacological agents; gene therapy
8. Biological agents and biosimilars
9. Drug delivery systems based on nanoparticles
10. Cell-based therapies

The following reference textbooks are recommended:
D.E. Golan, E.J. Armstrong, A.W. Armstrong: Principles of Pharmacology - The Pathophysiologic Basis of Drug Therapy. 4th Edition, 2016, Wolters Kluwer.
F. Clementi, G. Fumagalli: Farmacologia Generale & Molecolare, IV edizione aggiornata, EDRA.
The visual materials presented during the lectures can be found on the Moodle platform, compatibly with the laws on copyright.


The course consists of ex cathedra lectures, but aims at creating a direct interaction between students and teacher, in order to stimulate the students' involvement.
Lectures and the accompanying visual materials are a necessary, although not sufficient, source of information for the students. Thus, while consistent attendance is recommended, students are also strongly encouraged to refer to the recommended textbooks.

Prof. Monti will receive the students by appointment, to be scheduled by e-mail (