Methods in Pharmacology and Toxicology
A.Y. 2024/2025
Learning objectives
The course aims to introduce students to the main pharmacological and toxicological methodologies used in the various stages of the development of drugs and for the evaluation of the toxicity of substances.
Expected learning outcomes
After following the course of Pharmacological and Toxicological Methodologies, students will understand the processes that lead to the identification of a potential therapeutic target and the development of a drug in the pre-clinical and clinical phases. In particular, at the end of the course, the student will be able to: i) identify and understand the pre-clinical studies and models that are used to develop a potential drug; 2) know and apply the methodologies for evaluating the activity, pharmacokinetics and toxicity of a clinical candidate; 3) acquire knowledge on pre-clinical and clinical regulations; 4) understand the types of adverse effects and the factors conditioning the toxic effects of drugs; 5) describe biotechnological and nanotechnological drugs and associated pharmacological and toxicological aspects; 5) understand the basic principles of gene therapy and describe the associated pharmacological and toxicological aspects.
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
Course syllabus
1) In vitro studies and models for drug and toxicological screening
- identification of the drug target
- hints of drug screening and discovery
- pharmacological assays
2) In vivo studies and models to evaluate the efficacy of active molecules or drugs
- animal models of disease
- design of a preclinical study in animal models
- legislation for the use of laboratory animals
4) Hints of pharmacokinetics and pharmacodynamics
- Evaluation of the absorption, distribution, metabolism and elimination of a drug
- Evaluation of the drug-receptor relationship and the mechanism of action
5) Toxicology studies
- Acute and chronic toxicity test
- Mutagenicity test
- Carcinogenesis test
- Reproductive toxicity test (fertility, teratogenicity, peri and postnatal toxicity)
6) From experimentation in animals to humans and vice versa
- Clinical Trials Regulations
- Drug regulatory agencies and cost / benefit assessment
- Orphan drugs
7) Toxicity of drugs
- Pharmacology and toxicology of anticancer drugs
- Pharmacology and toxicology of substances of abuse
9) Pharmacogenetics
- Genetic polymorphisms in pharmacology
- Pharmacokinetic and pharmacodynamic processes influenced by polymorphisms
- The clinical relevance of polymorphisms
10) Biotechnological and nanotechnological drugs
- General features
- Classification
- Pharmacological and toxicological aspects
11) Pharmacological uses of nucleic acids and principles of gene therapy
- Definition of gene therapy
- Mechanism of action of nucleic acids for therapeutic use
- Nucleic acid delivery and delivery systems
- identification of the drug target
- hints of drug screening and discovery
- pharmacological assays
2) In vivo studies and models to evaluate the efficacy of active molecules or drugs
- animal models of disease
- design of a preclinical study in animal models
- legislation for the use of laboratory animals
4) Hints of pharmacokinetics and pharmacodynamics
- Evaluation of the absorption, distribution, metabolism and elimination of a drug
- Evaluation of the drug-receptor relationship and the mechanism of action
5) Toxicology studies
- Acute and chronic toxicity test
- Mutagenicity test
- Carcinogenesis test
- Reproductive toxicity test (fertility, teratogenicity, peri and postnatal toxicity)
6) From experimentation in animals to humans and vice versa
- Clinical Trials Regulations
- Drug regulatory agencies and cost / benefit assessment
- Orphan drugs
7) Toxicity of drugs
- Pharmacology and toxicology of anticancer drugs
- Pharmacology and toxicology of substances of abuse
9) Pharmacogenetics
- Genetic polymorphisms in pharmacology
- Pharmacokinetic and pharmacodynamic processes influenced by polymorphisms
- The clinical relevance of polymorphisms
10) Biotechnological and nanotechnological drugs
- General features
- Classification
- Pharmacological and toxicological aspects
11) Pharmacological uses of nucleic acids and principles of gene therapy
- Definition of gene therapy
- Mechanism of action of nucleic acids for therapeutic use
- Nucleic acid delivery and delivery systems
Prerequisites for admission
Good knowledge of anatomy, cell biology, biochemistry and general pharmacology are required. A good understanding of the English language is also required. Attendance is strongly recommended.
Teaching methods
The teaching method is based on interactive lectures supported by ppt slides as teaching material.
The student will be involved in actively participating in the discussion to improve their critical skills, reworking the concepts acquired.
The student will be involved in actively participating in the discussion to improve their critical skills, reworking the concepts acquired.
Teaching Resources
Material in pdf format, deposited in ARIEL, which includes:
slides shown during the lessons, original scientific manuscripts and Reviews relating to the topics covered.
Reference texts:
Farmacologia, Principi di base e applicazioni terapeutiche, F. Rossi, V. Cuomo, C. Riccardi
Farmacologia generale e molecolare, F. Clementi e G. Fumagalli
slides shown during the lessons, original scientific manuscripts and Reviews relating to the topics covered.
Reference texts:
Farmacologia, Principi di base e applicazioni terapeutiche, F. Rossi, V. Cuomo, C. Riccardi
Farmacologia generale e molecolare, F. Clementi e G. Fumagalli
Assessment methods and Criteria
The assessment method consists of a Multiple Choice Test and questions with open answer on the topics covered during the course in order to verify the level of knowledge and skills acquired. The vote is expressed out of thirty.
Professor(s)