THREE-DIMENSIONAL MODELING

Course objectives

The course aims to provide the student with basics in formulation of biotechnological drugs, as well as, development of conventional and innovative pharmaceutical dosage forms. To this end, the course aims to give adequate theoretical bases in order to make the student able to comprehend the relation between the properties of the different dosage forms and their biopharmaceutical and pharmacokinetic fate in vivo, considering the physico-chemical properties of the drug as well as the therapeutic objective. At the same time, the course aims to provide deep knowledge on different formulation strategies and analytical techniques to characterize the pharmaceutical forms. The course further aims to provide the student with knowledge about manufacturing, registration and commercialization of biotechnological drugs. Overall, the course aims to develop knowledge about the main formulation, manufacturing, quality and regulatory issues. At the end of the course, the student should demonstrate: 1) Knowledge and understanding skills on the following topics: - basics on formulation, manufacturing and quality control of the principal conventional and innovative dosage forms; - technological characteristics of the excipients; - theoretical bases of controlled release of drugs; - pharmaceutical legislation and regulation with focus on biotechnological drugs. 2) Applying knowledge and understanding The course aims to provide the student with general principles to optimize the efficacy of biotechnological drugs, taking into consideration the physico-chemical and stability properties of the active molecule as well as the administration route, the delivery vehicle and the targeting strategy more suitable to achieve the desired therapeutic effect. Therefore, the student will be able to follow the steps of the manufacturing process of medicines and to prepare the principal conventional and innovative dosage forms, taking into account potential formulation, regulatory and safety issues. 3) Making judgements At the end of the course, the student will write a report to demonstrate its ability to evaluate the technological, regulatory and safety issues related to the manufacturing of a conventional or innovative dosage form. 4) Communication skills During the course, some roundtables sessions will be carried forward under the direction of the professor to evaluate the communication skills of the student. These sessions will be important to develop the ability to critically evaluate technological, regulatory and safety issues related to the manufacturing of conventional or innovative dosage forms. They will also be useful to develop the ability to properly report this information to both expert and inexpert persons. 5) Lifelong learning skills The course will provide the student with theoretical basis and tools to develop independent lifelong learning skills, in order to make it able to further enrich its knowledge, thus maintaining it on a constant level. This point is particularly important considering the quick and incessant evolution of the pharmaceutical technologies and legislation.

Channel 1
FEDERICA RINALDI Lecturers' profile

Program - Frequency - Exams

Course program
National and supranational institutions. Functions of AIFA and role in the European context. Authorization procedures. GMP-Annex-ICH Inspection RCP Packaging Pharmacovigilance regulations, reporting systems for suspected adverse reactions and signal analysis. Risk minimization and risk communication measures in pharmacovigilance Biosimilars. Orphan drugs. Patent Regulatory Authorities: characterization, quality and safety control of biological drugs. Biotechnological drugs:legislation (DPC...)
Prerequisites
In order to guarantee a sufficient level of learning, useful for the student is the acquisition of knowledge about Pharmaceutical Technologies. Furthermore, the knowledge of basic formulation processes and some aspects of the methods of characterization of biotechnological medicines are necessary. Basic notions about toxicology and pharmacology are useful.
Books
P. Minghetti – Legislazione Farmaceutica (edizione corrente) – CEA Casa Editrice Ambrosiana – Milano. Farmacopea Italiana XII Ed. Farmacopea Europea Teaching and didactic materials (slides, scientific reports)
Teaching mode
lectures will be held in person (for a number of students equal to 80% From October 18/100% from November 22).Online learning will also be guaranteed
Frequency
Non mandatory attendance
Exam mode
The students will be asked to develop a personal/team research that starting from one of the topics development during the course, including various legislative aspects, production and control of biotelogical/biotech medicines supplemented if necessary by a written test (open answers). A minimum score of 18/30 is needed to pass this exam. As far as the overall evaluation of the exam is concerned, the final score will take into consideration how much the students are acquainted with the topics faced during the course, the logical evolution of the presentation of the proposed project as well as the skill and competences that were acquired. The use of an appropriate terminology during the presentation will also play an important role. Together with a check of the acquisition by the student of most aspects of the project proposed for the exam, it will be evaluated how wide and deep he/she is capable of discussing appropriately and logically the specific topic and to identify the noteworthy points of the problem that is faced. In particular: Failed exam: Poor or lacking knowledge and understanding of the topics; limited ability to analyze and summarize data and information, frequent generalizations of the requested contents; inability to use technical language. 18-20: Barely sufficient knowledge and understanding of the topics, with obvious imperfections; barely sufficient ability to analyze, summarize data and information, and limited autonomy of judgment; poor ability to use technical language. 21-23: Sufficient knowledge and understanding of the topics; sufficient ability to analyze, summarize data with the ability to reason with logic and coherence the required contents; sufficient ability to use technical language. 24-26: Fair knowledge and understanding of the topics; adequate ability to analyze and summarize data and information with ability to rigorously discuss the required contents; good ability to use technical language. 27-29: Good knowledge and understanding of the required contents; good ability to analyze and summarize data and information together with ability to rigorously discuss and present the required contents; good ability to use technical language. 30-30L: Excellent level of knowledge and understanding of the required contents with an excellent ability to analyze and synthesize data and information with the ability to discuss and present the required contents in a rigorous, innovative and original way; excellent ability to use technical language.
Bibliography
Link utili: Ministero della Salute ( https://www.salute.gov.it/portale/home.html) Ema (https://www.ema.europa.eu/en) AIFA (https://www.aifa.gov.it/en/web/guest/home)
Lesson mode
In accordance with the instructions of the University, reported at https://www.uniroma1.it/it/notizia/covid-19-fase-3-lezioni-esami-e-lauree-presenza-e-distanza, the lectures of the courses of all study courses (first degrees, master's degrees, doctoral courses, masters) are in presence, to the extent of 100% of the places originally usable for each classroom , also guaranteeing remote use to allow the participation of those who cannot secure a place in the classroom and / or for health reasons will not be able to participate in face-to-face activities. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. The lessons, that will be carried out “in presence”, will be supplemented with further explanations and checks following an applicative point of view. For a deeper insight, experts in the specific fields faced during the lessons will be invited.
  • Academic year2025/2026
  • CoursePharmaceutical Biotechnology
  • CurriculumSingle curriculum
  • Year2nd year
  • Semester1st semester
  • SSDCHIM/09
  • CFU3