Catalogo dei Corsi di studio

General expected learning outcomes
The general objective of the course is to grant the students the ability of correctly understand and describe an analytical problem, focusing in details on the design, development, optimization, validation and application of laboratory procedures for the analysis of drugs and metabolites in different biological fluids.
To successfully grant the above, it is mandatory: (i) to outline the main objectives of the pharmaco-toxicological analyses; (ii) to present the main biophysico-chemical features of both the analytical targets (drugs and/or their metabolites) and the analytical matrices (the different biological fluids); (iii) to ensure the knowledge of the main analytical procedures (instrumental and pre-instrumental) for the quali-quantitative analysis and the pharmaco-toxicological characterization of drugs and metabolites, from the identification of the analytical problem and the related sampling procedures, to the processing, interpretation and communication of the results.
The course also supplies information on the rules of the so called “scientific communication”, with specific attention given to the preparation and editing of internal laboratory procedures, scientific manuscripts (both research and review articles), conference communications (either oral and poster format) and the submission and reporting of research grants.

Specific expected learning outcomes
1 Knowledge and understanding
At the end of the course, the students will have acquired the basic know-how to understand the correct and most appropriate methodologies for the design, development, optimization, validation and application of analytical procedures for the analysis of drus and metabolites in biological fluids, taking into account (i) the specific aims and scope of the analytical investigation; (ii) the available biological matrix; and (iii) the most common instrumental techniques. The above will also be based on the access to databases and reference scientific literature.

2 Applying knowledge and understanding
The students will be able to design, develop, optimize, validate and apply analytical procedures – either newly realized and/or adapted from existing ones – for the analysis of drugs and metabolites in biological fluids. This will be accomplished taking into account the different, specific objectives of the analytical investigation (pre-clinical and clinical pharmaceutical research; therapeutic drug monitoring; clinical pharmaco-toxicology; emergency toxicology; forensic toxicology), at the same time critically evaluating the biophysico-chemical properties of the target compounds, and selecting the most appropriate biological matrices and instrumental analysis techniques.

3 Making judgements
The organization of the frontal lessons, highly interactive, paralleled by numerous practical exercises and simulations of case studies regularly presented during the course, will allow the students, once they will have acquired the basic knowledge of the subject, to critically pre-evaluate and propose the most appropriate analytical strategies to solve real problems related to the quali-quantitative analysis of drugs and their metabolites in biological fluids.

4 Communication skills
Special emphasis will be dedicated to the rules of the correct scientific communication, with special emphasis on the following formats: (i) research articles to be published on scientific journals in the field of pharmaco-toxicological analysis; (ii) conference presentation (both in form of poster and or oral communication); (iii) grant proposals; (iv) internal standard operative procedures, compliant with ISO17025/ISO15189; (iv) reports, expert opinions, technical briefs in the case of forensic investigations. Specific attention will be given to consolidate an adequate technical language to present, both in oral and written forms, the specific subjects of the course.

5 Learning skills
The students, also thanks to the support of both the basic textbook and the integrative scientific literature supplied in parallel to the frontal lessons, will be given the possibility to verify in real time his/her learning capacity; an “entry test” is planned at the beginning of the course, aimed to assess the pre-existing level of knowledge of the students, allowing to optimize the fine structure of the course to maximize learning, dedicating more time and attention to those topics that the students did not encounter in previous courses. Furthermore, two additional periodic tests will allow to verify, with a high degree of accuracy, the real level of learning. Special attention is dedicated to the integrative information that can be retrieved by accessing specific databases and the reference scientific literature.

Programme

The analytical problem in pharmaceutical chemistry, in experimental and clinical pharmacology, in therapeutic monitoring, in toxicology and in forensic sciences.
The main purposes of the analytical investigation. Analytical techniques, methods, procedures and protocols.
Procedures for the identification and quantitative determination of drugs and their metabolites in biological fluids. The "analytical profile" of a drug. Criteria for the choice and development of analysis methods for the identification and quantitative determination of drugs and metabolites in biological fluids and in in vitro model systems. Screening methods and confirmation methods.
Biological matrices; sample pretreatment techniques and main procedures for the extraction, purification, isolation and pre-concentration of the analytes of interest in biological fluids and in vitro model systems.
Main instrumental analysis techniques.
Methods for the processing and interpretation of experimental data according to the objectives of the analytical investigation.
Validation and accreditation of analysis methods and test procedures.
Planning a complete analytical protocol: from sampling to communication of results.
Bibliographic resources: the study and consultation of the reference scientific literature and databases.

Adopted texts

The Analysis of Drugs in Biological Fluids Second Edition Joseph Chamberlain