66631 - Pharmacological Biotechnology

Learning outcomes

At the end of this course, the students know the basic elements of pharmacokinetics and pharmacodynamics useful to investigate traditional and biotechnological drugs. The students will learn the basic concepts of the variability of action of different drugs and in different persons. At the end of the laboratory course, the students will possess adequate knowledge and practical capability to investigate, at preclinical level, the mechanisms of action of new drugs as well as of those already on the market.

Course contents

- General principles of pharmacodynamics: mechanisms of drug action, structure-activity relationship

- Evaluation of the drug effects. Drug concentration-response relationship. Therapeutic index.

- Receptor mechanisms of drug action and signal transduction mechanisms.

- Drug antagonism: competitive antagonism and partial antagonist.

- Modification of the drug response: hypersensitivity, desensitization, tolerance, tachyphylaxis.

- General principles of pharmacokinetics. Passive diffusion. Drug absorption and administration routes. Absorption kinetics. Analysis of the plasma concentration curve.

- Kinetics of drug elimination. Renal clearance and systemic clearance.

- Drug excretion and metabolism. Metabolic drug induction. Active metabolites. Influence of pathologies on pharmacokinetic.

- Introduction to main drug classes with aparticular attention to iinovative or biotechnological drugs:

- Principles of pharmacology of the central nervous system: gene therapy and cellular therapy for Parkinson disease and Alzheimer disease. Pharmacological therapy for lateral amyotrophic sclerosis.

- Principles of anticancer drug therapy: innovative drugs.

- Pharmacology of the endocrine pancreas.

- Principles of immunopharmacology.

- Innovative drugs for rheumatoid arthritis.

Laboratory course

Module I -Dr. Monica Baiula

Module II - Dr. Andrea Bedini

The students in the practical laboratory course of pharmacology will carry out the following experiments:

1) set up of a cell model to study drug-receptor interactions by a cell adhesion assay.

2) Evaluation of the signal transduction pathways of a G-protein coupled receptor exposed to agonists and/or to antagonists adopting a cell model expressing the recombinant receptor.

3) Analysis of the effect of glucocorticoids on gene expression in a lympocytic cell line.

Readings/Bibliography

In addition to the material that will be distributed by the teacher, the following textbooks are suggested:

− Golan DE et al. Principi di Farmacologia – Le basi fisiopatologiche delle malattie Casa Editrice Ambrosiana, Milano

−Rang HP, Dale MM, Ritter JM Farmacologia Casa Editrice Elsevier, Milano

− Katzung BG Farmacologia generale e clinica Piccin, Padova

− Birkett DJ Farmacocinetica facile Piccin, Padova

− Clementi F, Fumagalli G Farmacologia generale e molecolare UTET, Torino

-Stefano Govoni, Salvatore Cuzzocrea, Adele Lucchelli, Pierluigi Navarra, Marco Racchi, Francesco Scaglione, Santi Mario Spampinato. Farmacologia con sito web. Casa Editrice Ambrosiana, 2014

Teaching methods

Lessons in classroom, (PC - connection to specific web sites).

Assessment methods

The exam takes place in two stages: a) delivery of a detailed written report stating, in an analytical way, the experimental procedures and the results obtained in the laboratory course; b) a final written exam of 3 hours. In the written exam, it is not allowed to consult books, notes and computer media; this is structured in two parts. The first part consists of 10 open questions on the following topics: general principles of pharmacodynamics; mechanisms of drug action, structure-activity relationship; evaluation of the drug effects; drug concentration-response relationship; therapeutic index; receptor mechanisms of drug action and signal transduction mechanisms; drug antagonism; modification of the drug response; drug absorption and administration routes; analysis of the plasma concentration curve; kinetics of drug elimination; drug excretion and metabolism; metabolic drug induction; principles of autonomic and peripheral nervous system pharmacology. The second part consists of 10 open questions on the following topics: principles of cardiovascular pharmacology; principles of pharmacology of the central nervous system; principles of immunopharmacology; biotechnological drugs.

Each of the two parts of the written test will be awarded up to 10 points.

The test will be passed if it is achieved, in each part, a minimum score of 6/10.

The written report will be given ten days prior to the conduct of the written examination. The written report will be awarded up to 10 points. Only students with a grade equal to or greater than 6/10 will be able to take the written exam.

The vote on the entire course is calculated as the arithmetical mean of thirty,of the individual marks obtained in the written report and in the two parts of the written test.

Students who attend the course can participate to 2 partial tests. The first, will be done on the first days of November, on the topics of the first eight lessons: general pharmacodynamics: mechanisms of drug action; evaluation and measurement of the pharmacological effect; concentration-effect or dose-effect; therapeutic index; receptor-mediated mechanisms of action of drugs and mechanisms of signal transduction; definition and type of pharmacological and metabolic antagonism; modifications of the pharmacological response; general principles of pharmacokinetics, absorption and routes of administration of drugs; analysis of the plasma concentration curve; kinetics of elimination of the drug; excretion and metabolism of drugs, medicines of the autonomic nervous system and visceral function. The second test, done on the second part of January, on the topics of the last eight lessons: the principles of cardiovascular pharmacology, principles of pharmacology of the central nervous system antitumor principles of pharmacology; immunopharmacology; biotechnology drugs. Each test will be passed if the student has reached a minimum score of 6/10. The score obtained in the partial test can be recognized, if specifically requested by the student, as indicated above in the place of the final exam. The scores obtained in the partial tests are valid no later than September 30 of the academic year attended during the course. Thereafter, the student will afford the written exam.

Teaching tools

Projector for lessons and a well equipped laboratory for the practical course.

Office hours

See the website of Monica Baiula

See the website of Andrea Bedini