Clinical Pharmacology and Applied Biochemistry

A.Y. 2020/2021
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

Responsible
Lesson period
Second semester
Teaching methods:
for the Clinical Pharmacology and Applied Biochemistry teaching units, the lessons will be held remotely on the Microsoft Teams platform: asynchronous (lessons) and synchronous (exercises) mode.
For the Medical Genetics teaching unit, lessons will be held online via Microsoft Teams asynchronously. There will be weekly online sessions dedicated to student questions, discussion and insights on various topics. Recorded lessons are always made available on Ariel.
Program and reference material:
the program and reference material will not be affected.
Learning assessment procedures and assessment criteria:
the exam will take place in remote oral form using the Microsoft Teams platform.
If the situation allows it, the written exam for the teaching unit of Medical Genetics will take place in the classroom. Alternatively, the exam will take place using the platforms made available by the University to perform remote written exams, such as Exam.net.
The evaluation criteria will not change.
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.
The purpose of the Applied Biochemistry didactic unit is to provide participants with knowledge and understanding of some of the methodologies useful in clinical and research laboratories that employ biochemical and enzymatic approaches for diagnostic purposes and for the development of drugs and biotechnological products. The practical part will be based on the discussion of multiple choice tests and clinical cases.
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
Farmacologia - Principi di base e applicazioni terapeutiche di Rossi, Cuomo, Riccardi. 2019. Editore: Minerva Medica
Farmacologia clinica di Fucella, Perucca, Sirtori. 1998. Editore: UTET
Elisabetta Albi - Biochimica clinica essenziale. 2019 Biochimica Zanichelli
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
Professor: Gomaraschi Monica
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:
On Mondays, Wednesdays and Fridays from 9 to 10 am and on appointment previously taken via Microsoft Teams or email
Microsoft Teams
Reception:
upon request of an appointment