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Biotechnology and Pharmacotoxicology - Structure
Biotechnology and Pharmacotoxicology - Structure


EMANUELA CORSINI , responsible for the course

Degree in SAFETY ASSESSMENT OF XENOBIOTICS AND BIOTECHNOLOGICAL PRODUCTS (Classe LM-9) For students enrolled from 2015/16 academic year - Laurea Magistrale - 2017/2018

Compulsory course or activityyes
Year of course1s
Term or semester2nd semester
Scientific fields (settori scientifico-disciplinari)
  • BIO/14 - Farmacologia
ECTS credits (CFU) compulsory10
ECTS credits - facultative-


Syllabus Biotechnology and Pharmacology:

- Introduction:
a. the drug discovery process with an historical perspective
b. biotechnology in drug development and in the prediction of adverse reactions
- Biologics: biotechnology applied to the identification, generation and production of current available drugs.
a. Therapeutic proteins
b. Vaccines
c. Monoclonal antibodies
d. Epigenetic drugs
e. Gene therapy
f. Drugs targeting transcription factors
g. Nucleic acids as drugs
- Small molecules and biotechnological drugs:
a. differences in drug development - practical examples
b. differences in the toxicology analysis – practical examples
c. new tools for the drug pharmacotoxicological analysis – practical examples

Readings Biotechnology and Pharmacology:

Ho RJY, Gibaldi M
Biotechnology and Biopharmaceuticals

Syllabus Genotoxicology, Cancerogenicity, Reproductive and Developmental Toxicity:

Modern toxicology involves the study of structure and mechanism related to the toxic effects of chemical agents, and encompasses technology advances in research related to chemical aspects of toxicology. Toxicology is strongly multidisciplinary, spanning computational chemistry and synthetic chemistry, proteomics and metabolomics, drug discovery, drug metabolism and mechanisms of action, bioinformatics, bioanalytical chemistry, chemical biology, and molecular epidemiology.

The main purposes of this module are:
1. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive toxic effects of xenobiotics.
2. to characterize their molecular mechanisms of action.
3. to provide notions on preclinical toxicology for product development and the EU legislations concerning the following endpoints: genotoxicity, cancerogenicity, immunotoxicity, reproductive and developmental toxicity.
Lectures will be dedicated to the introduction of the different topics and their toxicological evaluation, while the tutorials will be dedicated to the discussion of case studies with a direct involvement of students.

Learning will be assessed by an oral examination of approximately 30 minutes on the topics and issues related to the evaluation of these critical toxicity endpoints as discussed during lectures.

Readings Genotoxicology, Cancerogenicity, Reproductive and Developmental Toxicity:

Curtis D. Klaassen
Casarett and Doull's Toxicology: The Basic Science of Poisons 8th Edition
Mc Graw Hill Education, 2013
ISBN: 978-0-07-17622-8

Prerequisites, exams and assessment

Type of assessmentEsame
Assessmentvoto verbalizzato in trentesimi

Prerequisites, exams and assessment The course requires the knowledge of the main notions of biology, physiology, anatomy, biochemistry and chemistry. The examination consists of an approximately 30 min oral examination. The examination covers all the topics presented during lectures and it consists of a series of questions, which aims to verify that the course objectives have been achieved.
Exam: single
Typer of assessment: oral exam
Assessment: vote recorded in thirtieth

Structure of the course

Biotechnology and Pharmacology, Biotechnology and Pharmacology

Aims and objectivesThe aim of the course is to provide the basic knowledge for understanding the process of drug discovery that was applied to the development of the currently available biotechnological drugs and to give a prospective view on the next-generation drugs. Lectures will introduce students to the field with an historical perspective and will provide examples for each of the distinct categories (protein, nucleic acids etc). Finally, differences in development and toxicological analysis between biotech drugs and small molecules will be analyzed and discussed.

Scientific fields

  • BIO/14 - Farmacologia - Credits:5

Lectures: 40 hours


Genotoxicology, Cancerogenicity, Reproductive and Developmental Toxicity, Genotoxicology, Cancerogenicity, Reproductive and

Aims and objectivesThe course will familiarize the students with current knowledge on xenobiotics able to interact and damage cell genetic information and potentially cause of disease. The focus of the course will be on the direct or indirect mechanisms leading to DNA damage causing permanent, heritable, alterations in either somatic or germ cells. The course will also illustrate the mechanisms of cell defence to genotoxic events, with a particular emphasis of the processes of DNA repair and cell death (apoptosis, autophagy, necrosis etc.).
In addition, the property and the classification of chemical, biological, or radionuclide agents directly involved in causing cancer will be illustrated: the main classification provided is based on the mode of action which divides xenobiotics into genotoxic or non-genotoxic agents. Particular focus will be given not only to the DNA damaging agents, but also to those affecting metabolic processes both natural and synthetic substances. Finally, the course will give a complete overview of the methodologies applied to measure carcinogens.
Starting from the description of the possible structural or functional alterations (reversible or irreversible), which interferes with homeostasis, normal growth, differentiation, development or behaviour, the course will focus on the environmental insults with teratogenic potential including drugs, lifestyle factors (such as alcohol, diet), environmental toxic chemicals, or physical factors.

Scientific fields

  • BIO/14 - Farmacologia - Credits:5

Lectures: 32 hours

Tutorials: 16 hours

Teachers ' office hours

Teacher's office hours
TeacherOffice location
EMANUELA CORSINI , responsible for the coursePrevio appuntamento telefonicoDip. di Scienze Farmacologiche, Via Balzaretti 9
PAOLO CIANAVenerdi ore 10.00 12.30Dip. di Scienze Farmacologiche, Via Balzaretti 9