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 drug discovery and development studies (functional assays, binding, biochemical tests, holistic and reductionist systems, pre-clinical, clinical and observational studies) and their specific regulatory aspects (knowledge and understanding),
2.TO USE THE KNOWLEDGE AND UNDERSTANDING ACQUIRED, so that the student will be able to propose the experimental approaches to be carried out in the characterization of pharmacological, therapeutic and toxicological properties of drugs in the preclinical and clinical context (applying knowledge and understanding),
3.TO ANALYSE AND INTERPRET correctly and critically the results of
virtual experiments (independence of judgment)
4.TO CONSULT scientific databases (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 EXPERIMENTAL PHARMACOLOGY course provides theoretical and practical insights into pharmacodynamics and pharmacokinetics (with determination of quantitative parameters), and provides a detailed description of the experimental methods applied in the study of drugs in systems with different degrees of complexity in vivo and in vitro. Design of the protocol, production and acquisition of results from preclinical and clinical studies, statistical analysis of data, interpretation in the light of scientific literature and their dissemination are presented. Emphasis is placed on the laws governing preclinical and clinical trials.
The student can participate in a series of practical lessons concerning:
Pharmacological experiments: construction of dose-response curves, preparation of a cell culture, determination of proteins and metabolites content, calibration curves, statistical analysis of the results through the application of descriptive and inferential principles of statistics.
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. DLgs 26/2014, Principles of 3R.
Management of animal housing and lab animal characteristics.
Experimental approach for the qualitative and quantitative evaluation of biological responses to drugs: experimental design, sources of variability, methods and techniques in vivo, ex vivo and in vitro, functional and binding studies.
Experimental models for the study of therapeutic efficacy of new molecules. Transgenic animals.
Pharmacokinetic aspects: mode of administration in vivo and pharmacokinetics in vitro and in vivo.
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: Biological units and international standards.
Cell culture and molecular biology techniques (western blot, PCR).
Assessment of toxicity and definition of the therapeutic index: 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 activities consists of:
1. experiments carried out in the laboratory as part of specific research programs (study of cell viability, production of concentration-response curves, dosing of proteins, inflammatory mediators and glucose, calibration curves, preparation of a cell culture).
2. 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 material (slides and scientific articles) is made available by the teacher on Elly platform to students .
Useful texts for consultation are:
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 course comprises frontal lessons and practical experiments.
Experimental activities are performed by every student in single location in laboratories. Learning materials and short video-recordings concerning experiments are available in Elly platform.
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 in the laboratory or in exercises of statistical analysis of data. Groups of students will be driven in the organization and presentation of seminars using power-points, and through the 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.
To promote the active participation of the students the teacher uses Elly sources addressed toward single students or small groups
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.
Questions concern the theoretical contents of the course and virtual experimental situations.
The exam demonstrates 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 (requirements to pass the examination as 18/30), 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 (12/30).
Praise is given if the highest score on each question is reached. Online registration on Elly platform is compulsory.
Other information
At the beginning of the course the student will be 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.
Access to the laboratory is subject to the successful acquisition of suitability for the Workplace Safety Course (certificates) and to the signing of a form certifying that information has been provided on the rules and behaviors to be adopted in the laboratory.
