509952 - BIOTECHNOLOGICAL DRUGS FORMULATION & REGULATORY ASPECTS

insegnamento

ID:

509952

Durata (ore):

52

CFU:

SSD:

FARMACEUTICO TECNOLOGICO APPLICATIVO

Anno:

2026

Periodo di attività

Primo Semestre (28/09/2026 - 15/01/2027)

Obiettivi Formativi

The aim of the course is to provide students’ knowledge and proper competences in pharmaceutical technology related to the different types of pharmaceutical dosage forms, whose formulation technology and biopharmaceutical aspects are introduced together with regulatory aspects governing the pharmaceutical field with focus on pharmaceutical biotechnology and related drug products.

Prerequisiti

Basic notions of organic chemistry, analytical chemistry and preliminary knowledge in the field of the design and development formulations.

Metodi didattici

The teaching is based on lectures and laboratory activities. Students will be involved in group works.
For carrying out the frontal lessons, Power Point presentations are used, made available to students in the section dedicated to teaching on the moodle KIRO platform. Moreover, EMA and ICH guidelines related to regulatory topics are made available for students on kiro platfomrs.

Verifica Apprendimento

The examination consists of a written examination in which it is necessary to discuss from the technological point of view the pre-formulation and formulation development of a biotechnological product on the market.
The part of the written exam relating to regulatory aspects includes 2 open questions.
Exam dates will be published on the DDS website.
Attendance is not mandatory, but it is highly recommended, as the lessons are interactive and engaging. The final grade is calculated as follows: 10% for group work, 10% for course participation and attendance, and 80% for the final exam.

Testi

Martin's Physical Pharmacy and Pharmaceutical Sciences: Physical Chemical and Biopharmaceutical Principles in the Pharmaceutical Sciences, Patrick J. Sinko, 6th Edition, Lippincott Williams and Wilkins Ed.
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines

Contenuti

- Pharmacokinetics of the various routes of administration.
- Biopharmaceuticals with particular reference to oral and other preparations
- formulation of proprietary medicinal products
-Regulatory framework of medicinal products for human use with particular focus on biotechnological pharmaceutical products. Regulatory bodies, the main procedures for registering medicines and issuing marketing authorizations. The registration dossier (CTD).

The course includes a practical part with laboratories of formulation technology and controls.

Lingua Insegnamento

INGLESE

Altre informazioni

All teaching materials are uploaded to the Kiro platform.

For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs.