OVERVIEW

The Experimental Pharmacology module is intended for third-year students of the Single-Cycle Master’s Degree in Pharmaceutical Chemistry and Technology and is worth 3 ECTS credits, corresponding to 24 hours of lectures. It aims to present the main in vitro, ex vivo, and in vivo experimental techniques used to design preclinical studies of newly formulated drugs, and to discuss their advantages and limitations. Specifically, students will learn laboratory techniques to investigate the mechanism of action and potential toxicity of a newly formulated drug, as well as methods to validate its efficacy.

AIMS AND CONTENT

LEARNING OUTCOMES

The Experimental Pharmacology module aims to present and discuss the main experimental techniques that must be carried out for the preclinical validation of a newly formulated drug before it can proceed to clinical trials in humans and subsequently be marketed.

AIMS AND LEARNING OUTCOMES

The course aims to present the main experimental methodologies that can be performed in vitro, ex vivo, and in vivo to evaluate the mechanism of action, efficacy, and toxicity of a newly formulated drug.

At the end of the course, the student will be able to:

1. Describe the main experimental methodologies used in experimental pharmacology studies.
2. Distinguish between in vitro, ex vivo, and in vivo approaches, evaluating their advantages, limitations, and applications.
3. Identify the most appropriate experimental models for studying a drug at its different stages of preclinical development (in vitro, ex vivo, and in vivo).
4. Design a complete preclinical study of a drug (i.e., combine in vitro, ex vivo, and in vivo methodologies to determine its efficacy and potential toxicity) and present it using appropriate scientific language.

PREREQUISITES

Knowledge of basic notions of pharmaceutical chemistry, biochemistry, organic chemistry, pharmacology and toxicology, animal biology.

TEACHING METHODS

The course is organized in frontal lessons. The topics will be illustrated by the teachers through Powerpoint presentations that are shared on the module TEAM.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department ( Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 7 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni

SYLLABUS/CONTENT

Experimental Pharmacology: introduction to experimental pharmacology as an experimental approach for the qualitative and quantitative evaluation of the action of a newly formulated drug (experimental design with the application of in vitro, ex vivo, and in vivo methodologies and techniques); overview of the preclinical development pathway of a drug before it reaches the market; use of immortalized cell lines, primary cultures, and iPSCs for in vitro studies; application of the main functional assays and molecular techniques to define the effects of the drug under investigation (e.g., cell viability and metabolism assays, analysis of gene modulation and protein expression of biological targets potentially affected by the drug) using 2D in vitro models; description of the main advantages and limitations of 2D in vitro models and introduction to advanced 3D in vitro models with or without scaffolds (spheroids, organoids, organ-on-chip systems, and 3D bioprinting); description and application of the main ex vivo methodologies for preclinical drug studies (acute slices, organotypic slices, isolated and perfused organs) and related experimental analyses; legislation and ethical regulations governing the use of animals in research and preclinical studies; selection of the most appropriate animal model; description of the main animal models of disease (spontaneous or induced); overview of the principal behavioral, cognitive, and motor assays used in laboratory animals to assess the efficacy and potential toxicity of the drug; presentation of an example of preclinical study design for a drug used in the treatment of amyotrophic lateral sclerosis; brief outline of the steps required to translate preclinical studies into clinical trials.

RECOMMENDED READING/BIBLIOGRAPHY

The official text of the experimental pharmacology consists of the didactic material prepared and distributed during the course, as well as the scientific literature which will be suitably provided for each topic.

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

The timetable for this course can be found at: EasyAcademy Portal, second semester

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam will consist of an oral test covering the topics addressed during the course. The examination will take place at the same time as the Drug Design module exam. The final grade will be the average of the marks obtained in the two modules.

ASSESSMENT METHODS

During the examination, the student will be required to demonstrate the knowledge acquired during the course, also by making connections with skills developed in related disciplines. The student will also be able to discuss the exam topics using appropriate scientific language.

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet