Learning objectives
At the end of the course of EXPERIMENTAL PHARMACOLOGY the student will be able
1.TO KNOW AND UNDERSTAND the pharmacological investigation techniques applied in the researches for drug discovery and development (functional studies, binding, biochemical tests, holistic and reductionist systems, pre-clinical, clinical and observational studies) (knowledge and understanding),
2.TO USE THE KNOWLEDGE AND UNDERSTANDING ACQUIRED, so that he will be able to propose experimental approaches to be carried out in the characterization of drugs, (applying knowledge and understanding),
3.TO ANALYSE AND INTERPRET correctly and critically the results of virtual experiments (independence of judgment)
4.TO CONSULT scientific database (learning ability)
5. TO COMMUNICATE the contents of scientific articles concerning topics of a bibliographic research performed by student groups (communication skills)
Prerequisites
Basic knowledge of Pharmacology and Pharmacotherapy
Course unit content
The lessons concern EXPERIMENTAL PHARMACOLOGY insights, from a theoretical point of view and practical aspects related to the pharmacodynamics and pharmacokinetics (with determination of their quantitative parameters), and detailed description of the experimental methods applied in the study of the effects of drugs in systems with different degree of complexity in vivo and in vitro. Production and acquisition of results from preclinical and clinical studies, statistical analysis of data, interpretation in the light of scientific literature and their communication are presented.
The student can participate in a series of practical lessons of EXPERIMENTAL PHARMACOLOGY concerning:
Participation in pharmacological experimentations at different degree of complexity.
Production and acquisition of experimental results processing statistical analysis through the application of descriptive and inferential principles.
Full programme
The course consists of lectures and practical exercises on the following topics:
Aims and importance of experimentation in Pharmacology. Legislation for use and care of animals in the scientific research. Principles of 3R.
Experimental approach for the qualitative and quantitative evaluation of biological responses: experimental design, sources of variability, methods and techniques in vivo, ex vivo and in vitro functional and binding studies, clinical trials.
Experimental models for the study of therapeutic efficacy of new molecules. Transgenic animals.
Pharmacokinetic aspects: mode of administration in vivo and pharmacokinetics in vitro.
Elements of molecular pharmacology: drug-receptor interaction, agonists and antagonists, potency and efficacy, affinity and intrinsic efficacy of drugs; evolution of receptor theory, stimulus-response coupling systems, processes of desensitization.
Bioassay: Unit biological and international standards.
Cell culture and molecular biology techniques (western blot, PCR).
Assessment of toxicity and definition indexes handling of drugs: safety pharmacology, explorative and regulatory toxicity studies.
Clinical and observational studies, meta-analysis.
Elements of statistics and application examples: individual variations in the biological response, the frequency distribution curve, probit, the confidence limits of the mean, parametric (t-test, analysis of variance) and non-parametric tests linear regression analysis. Meaning and analysis of the experimental data with the use of statistical programs.
Discussion of a bibliographic research prepared by groups of students.
The part of the course concerning practical activity consists of:
Participation in experiments carried out in the laboratory as part of specific research programs. During this activity the student can learn the features and the properties of the experimental models used in pharmacology.
Application of statistical tests for the analysis of experimental data:
the frequency distribution curve, the confidence limits of the mean, parametric (t-test, analysis of variance) and non-parametric tests (Chi square test), linear regression analysis, Schild analysis.
Bibliography
Teaching materials (slides e scientific articles) are loaded onto the Elly platform before the lesson and made available to students after online registration.
Books for further information:
GOODMAN & GILMAN S. The Pharmacological Basis of Therapeutics McGraw-Hill
DOLARA P, FRANCONI E, MUGELLI A: Farmacologia e Tossicologia Sperimentale Pitagora Editrice, Bologna.
PAOLETTI R et al: Farmacologia generale e molecolare UTET
KENAKIN T: A Pharmacology Primer, Elsevier
Teaching methods
The teaching is done through lectures supplemented by individual and group exercises.
The theoretical aspects of experimental pharmacology (dose-response relationship, gradual and quantal curves, determination of potency and affinity for agonists and antagonists) are presented and commented in a dialogic form and applied in practical lessons with student participation in drug assays conducted in the laboratory or simulations of experiments performed in classroom or exercises in statistical analysis of data. Groups of students are driven in the organization and presentation of seminars, through consultation of bibliographic sources. These activities are designed to reinforce in each student the ability TO INTEGRATE KNOWLEDGE, TO ANALYZE CRITICALLY complex issues and TO COMMUNICATE clearly their own conclusions.
The teacher is available by appointment (e-mail) for lesson explanations.
Assessment methods and criteria
ORAL EXAMINATION allows the assessment of learning. The exam is evaluated on a 0 -30 scale and the vote is immediately announced at the end of the test. Each examination takes about 30 minutes.
Through questions regarding the theoretical content of the course it will be determined whether the student has achieved the goal of KNOWLEDGE AND UNDERSTANDING of the basic principles of pharmacological experimentation, if the student has the ability of APPLYING THE ACQUIRED KNOWLEDGE in solving new and complex problems, if he is able TO CONNECT critically the different topics and demonstrates ACQUISITION OF LEARNING SKILLS and he has the ABILITY TO COMMUNICATE clearly the pharmacological arguments. The examination will be completed considering also the answers to questions about virtual experimental situations.
Other information
At the beginning of the course the student is informed of the right to express objection to animal experimentation in compliance with Law no. 413 of 12.10.1993 and invited to sign a form attesting the information process
