Clinical Pharmacology and Applied Biochemistry

A.Y. 2019/2020
9
Max ECTS
88
Overall hours
SSD
BIO/10 BIO/14 MED/03
Language
Italian
Learning objectives
The objective of the course to provide the students with the skills to understand how to design and interpret clinical trials with biologicals and biotech drugs; how to integrate information resulting from medical genetics to identify patients who will benefit the most from certain pharmacological treatments or who will be more exposed to side effects; how to use advanced biochemistry methods for research and development of novel bioactive molecules and for the evaluation of their mechanism of action.
Expected learning outcomes
Students attending the course will be able to evaluate clinical trial design and the clinical development phases of a biotechnological drug. Students will be able to understand how to identify the primary and secondary endpoints of a clinical study, to discuss the main aspects related to pharmacogenetics and pharmacogenomics clinical trials. Moreover they will learn key concepts of pharmacoepidemiology. Finally students will aquire knowledge on the standard operative procedures and the description of the different subjects involved in clinical research and market access in the biotechnological drugs filed
Course syllabus and organization

Single session

Lesson period
Second semester
Course syllabus
Clinical pharmacology will provide students with the skills to analyze drugs and their effects, to examine the benefits of biotechnological drugs approved for the treatment of several rare diseases, to discuss the aspects related to pharmacogenetics and pharmacogenomics as well pharmakokinetics.
It will be discussed how to design a clinical trial as well as how to interpretate the results from clinical trials, including the definition of primary and secondary endpoints. A special focus will be given to therapies based on the use of monoclonal antibodies and gene silencing approaches in the field of cardiometabolic disorders. Several aspects associated to genetic experimentation, genetic medicine, pharmaco surveillance and epidemiological medicine will be discussed.
The module of Medical genetics intends to provide students with the fundamental principles of inheritance, the genetic mechanisms underlying Mendelian and non-Mendelian diseases and related genetic tests. Another purpose of the module is to provide a general knowledge of the main methods used in the field of human molecular genetics, through examples of identification of the gene responsible for a genetic disease and examples of cellular and gene therapy.
Purpose of teaching of Applied Biochemistry is to provide participants knowledge on: main biochemistry methodologies applied in research labs for development of novel drugs and biotechnological products; methods aimed at evaluating structural modifications of biotechnological drugs with respect to the desired biological activity; biochemical and enzymatic methodologies useful in clinical biochemistry.
Prerequisites for admission
The following prerequisites are required for the applied biochemistry teaching unit: knowledge of anatomy, physiology, pathology, pharmacology, biochemistry and molecular biology.
Teaching methods
Interactive teaching and specific lessons with power point presentations. Single seat practical training.
Teaching Resources
Adkinson, Brown - Genetica medica, ed. Elsevier
Clementi - Elementi di Genetica medica, ed. EdiSes
Rossi-Farmacologia, Ed Minerva
Maccarone, Metodologie biochimiche e Biomolecolari, Biochimica Zanichelli, 2019
Assessment methods and Criteria
Practical and oral tests on the topics discussed during the course
Biochimica applicata
BIO/10 - BIOCHEMISTRY - University credits: 0
BIO/14 - PHARMACOLOGY - University credits: 0
MED/03 - MEDICAL GENETICS - University credits: 0
Single bench laboratory practical: 16 hours
Lessons: 16 hours
Professor: Eberini Ivano
Farmacologia clinica
BIO/10 - BIOCHEMISTRY - University credits: 0
BIO/14 - PHARMACOLOGY - University credits: 0
MED/03 - MEDICAL GENETICS - University credits: 0
Single bench laboratory practical: 16 hours
Lessons: 16 hours
Genetica medica
BIO/10 - BIOCHEMISTRY - University credits: 0
BIO/14 - PHARMACOLOGY - University credits: 0
MED/03 - MEDICAL GENETICS - University credits: 0
Lessons: 24 hours
Professor: Petroni Katia
Professor(s)
Reception:
upon request of an appointment