54744 - Drug Science

Learning outcomes

The course aims to provide skills on the fundamental principles that concern drug development. The course offers the pharmacological preparation that supports the profession of the nutritional and forensic biologist. At the end of the course, the student is able to plan development projects of an innovative drug, for a pathology important for a global market. The student acquires the necessary skills on the main classes of drugs and on how to recognize the relative interactions, the effects of nutrition on the action of the active ingredients, the influence of drugs on the nutritional state.

Course contents

Module 1

A drug is born: research and development process

Drug discovery

Preclinical experimentation

Clinical trial

Registration dossier and leaflet

Marketing authorization procedures

Pharmacovigilance

Notes on some classes of drugs:

Drugs used in dyslipidemias

Antiobesity drugs

Anticoagulant drugs

Anti-gout medications

Thyroid and antithyroid drugs

Anti-diabetic drugs

Oral contraceptives

Sedative-hypnotic and antidepressant drugs

Antihypertensive drugs and used in heart failure

Drugs used for reflux and gastric ulcer

Drugs and intestinal motility

Drug interactions: pharmacokinetic and pharmacodynamic interactions

Effect of nutrition on the action of drugs: modification of absorption, metabolism and elimination of drugs by the diet; influence of drugs on nutrient absorption.

Effect of drugs on nutritional status: drugs that interfere with taste perception; drugs that modulate hunger and satiety; weight gain as a side effect of medications.

Practical support. Sources of documentation. Consultation databases and websites on clinical trials. Database and websites available for information and updates on the pharmacological and pharmacotherapeutic profile of drug interactions.

Module 2

Preclinical quantitative pharmacokinetics (PK): critical parameters and prediction.

In vivo PK studies.

From animals to humans: algorithms for conventional and biological drugs.

General toxicity studies.

Safety pharmacology.

Reproductive toxicity studies.

Genetic and epigenetic “safety” studies.

From conventional to oncological, biological and vaccine drugs, differences.

 

 

Readings/Bibliography

The teaching material consists of the recommended textbooks and the material made available to students on the dedicated website. The teaching material provided on the dedicated website and the notes taken in class are essential for preparing for the exam.

The teaching material presented in class is not a substitute for the reference texts but rather an integration of these, and constitutes a guide for the selection and understanding of the topics to be covered.

Reference texts:

Farmacologia Generale e Clinica. B.G. Katzung, VII Ed. Italiana, Casa Editrice Piccin ~ Nuova.

Farmacologia clinica. L.M. Fuccella, E. Perucca, C. Sirtori, Casa Editrice UTET, Torino.

Farmacologia e tossicologia sperimentale. P. Dolara. Pitagora Editrice, Bologna.

Elementi di Tossicologia. Casaret & Doull. Casa Editrice Ambrosiana, Milano, ed. 2013.

 

 

Teaching methods

Module 1

The teaching is divided into lectures, seminar activities and discussion. The lectures will be held in person or remotely depending on the indications of the academic bodies. The lectures include the projection of slides useful to students as a guide for the explanation. The student can interact with the teacher to ask for clarifications regarding the topic covered. The teaching material will be distributed to students on the dedicated website.

Module 2

The teaching is divided into lectures (in person or remotely depending on the indications of the academic bodies), interactive activities with experts in the sector and discussion. Some lessons will be held following an innovative teaching approach (blended learning - in person and remotely) which includes the integration of the lectures with interactive activities developed together with experts from multinational pharmaceutical companies remotely; students may be divided into independent work groups. The teaching material will be distributed to students on the dedicated website.

Assessment methods

The learning assessment takes place through an oral exam in person or remotely depending on the provisions of the academic bodies and the preparation of a written term thesis.

The student, at least one week before the date of the oral exam, must send a written term thesis (in word, pdf or ppt format) to the teacher Donatella Canistro [mailto:donatella.canistro@unibo.it]. The term thesis must constitute an in-depth study of a topic (chosen by the student) covered in Module 2. The term thesis, if positively evaluated, will be valid for the current academic year.

During the oral exam (divided into at least three questions, lasting approximately 30 minutes), the student's ability to deal transversally and critically with the topics proposed as content of the teaching will be assessed. The student's demonstration of mastery of the subject, critical ability and possession of specific language will be evaluated with excellent marks. Lack of orientation in the topics covered during the course, training gaps and inappropriate language will determine negative evaluations.

The grade obtained will be used, in conjunction with that of the Hygiene teaching, to calculate the weighted average that will constitute the final grade of the Integrated Course.

Teaching tools

The teaching material presented in class will be made available to the student in electronic format, on the website http://virtuale.unibo.it. Username and password are reserved for students enrolled at the University of Bologna.

“Students with DSA or temporary or permanent disabilities: it is recommended to contact the competent University Office in good time (https://site.unibo.it/studenti-con-disabilita-e-dsa/it). It will be the responsibility of the Office to propose any adaptations to the students concerned, which must however be submitted, at least 15 days in advance, to the approval of the teacher, who will evaluate the appropriateness also in relation to the educational objectives of the course.”

Office hours

See the website of Donatella Canistro

See the website of Moreno Paolini