Clinical Pharmacology and Applied Biochemistry
A.Y. 2024/2025
Learning objectives
The general objective of the course is to provide students with knowledge and understanding of:
- the clinical phases of development of biological and biotechnological drugs;
- the design and interpretation of observational and intervention studies;
- the use of biochemical, genetic, and cellular information to identify patients who may benefit the most from pharmacological treatment or who may potentially be more susceptible to side effects;
- the therapeutic monitoring and vigilance of biological and biotechnological drugs;
- some of the methodologies useful in clinical and research laboratories employing biochemical and enzymatic approaches for diagnostics and the development of drugs and biotechnological products.
- the clinical phases of development of biological and biotechnological drugs;
- the design and interpretation of observational and intervention studies;
- the use of biochemical, genetic, and cellular information to identify patients who may benefit the most from pharmacological treatment or who may potentially be more susceptible to side effects;
- the therapeutic monitoring and vigilance of biological and biotechnological drugs;
- some of the methodologies useful in clinical and research laboratories employing biochemical and enzymatic approaches for diagnostics and the development of drugs and biotechnological products.
Expected learning outcomes
By the end of the course, students will be able to critically evaluate:
- the quality and design of a clinical study of a biotechnological drug;
- the processes of identification and validation of the endpoints in a clinical study;
- the potential and limitations of the most well-known diagnostic methodologies using biochemical and enzymatic approaches.
Students will also gain knowledge on aspects related to:
- pharmacoepidemiology and pharmacogenomics;
- pharmacovigilance;
- the related operational roles in the field of clinical research of biotechnological drugs.
Students will obtain a set of biochemical and pharmacological knowledge useful for further personal study and deepening of this subject.
- the quality and design of a clinical study of a biotechnological drug;
- the processes of identification and validation of the endpoints in a clinical study;
- the potential and limitations of the most well-known diagnostic methodologies using biochemical and enzymatic approaches.
Students will also gain knowledge on aspects related to:
- pharmacoepidemiology and pharmacogenomics;
- pharmacovigilance;
- the related operational roles in the field of clinical research of biotechnological drugs.
Students will obtain a set of biochemical and pharmacological knowledge useful for further personal study and deepening of this subject.
Lesson period: Second semester
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
Course syllabus
The study of clinical pharmacology aims to provide students with the ability to analyze drugs and the mechanisms that regulate their effects. It examines the benefits of biotechnological drugs approved for the treatment or prevention of many serious diseases. Additionally, clinical pharmacology evaluates the laws and mechanisms by which a drug is absorbed, metabolized, and eliminated in the body. The roles of various actors in clinical trials, ethical aspects of experimentation, pharmacovigilance, and pharmacogenomics studies are also considered. Finally, the importance of therapeutic drug monitoring is emphasized.
As for the Applied Biochemistry teaching unit, its purpose is to provide students with knowledge and understanding of useful methodologies in clinical and research laboratories. These methodologies employ biochemical and enzymatic approaches for diagnostics and the development of drugs and biotechnological products. The practical component of this unit will involve discussions of multiple-choice tests and clinical cases.
As for the Applied Biochemistry teaching unit, its purpose is to provide students with knowledge and understanding of useful methodologies in clinical and research laboratories. These methodologies employ biochemical and enzymatic approaches for diagnostics and the development of drugs and biotechnological products. The practical component of this unit will involve discussions of multiple-choice tests and clinical cases.
Prerequisites for admission
For teaching units, the following prerequisites are required: knowledge of genetics, anatomy, physiology, pathology, pharmacology, biochemistry, and molecular biology.
Teaching methods
The teaching method is based on interactive frontal lessons with the projection of educational material and mandatory individual workshops (ESEPS)
Assessment methods and Criteria
The examination test is oral and consists of a series of questions aimed at verifying the student's mastery of the topics covered in the course, presented using appropriate vocabulary. The evaluation is expressed as a grade out of thirty.
BIO/10 - BIOCHEMISTRY - University credits: 4
BIO/14 - PHARMACOLOGY - University credits: 5
BIO/14 - PHARMACOLOGY - University credits: 5
Single bench laboratory practical: 16 hours
Lessons: 64 hours
Lessons: 64 hours
Professors:
Eberini Ivano, Gomaraschi Monica
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:
By appointment
Centro E. Grossi Paoletti, Ospedale Niguarda, Piazza Ospedale Maggiore 3