Biotechnological Drugs: Pharmaco-Toxicological Aspects and Pharmaceutical Regulatory Affairs and Patents

A.Y. 2024/2025

Max ECTS

Overall hours

SSD

BIO/14 CHIM/09

Language

Italian

Included in the following degree programmes

Pharmaceutical Chemistry and Technology (Classe LM-13)-Enrolled from 2009/10 Academic Year Until 2020/21

Pharmaceutical Chemistry and Technology (Classe LM-13)-Enrolled from 2021/22 Until 2022/23 Academic Year

Learning objectives

The purpose of the course is to introduce the students to the pharmacology (pharmacokinetics, toxicity and pharmacodynamics), the relevant European Community legislation concerning Marketing Authorization (MA) and patents of new biotechnological medicinal products, including biosimilars.

Expected learning outcomes

The student will acquire the knowledges needed to understand how monoclonal antibodies (and biosimilars) work, how they can be used in the treatment of several pathologies, how to evaluate their toxicological profile and the legislative aspects and patents.

Lesson period: Second semester

Lessons timetable

Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi

Exams calendar

Single course

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Course syllabus and organization