2nd year training activities
STATISTICS AND CHEMIOMETRICS – (6 ECTS)
Aim of the course is to provide the students with basic concepts for IT data management. The course will face problems related to data analysis, design and implementation of investigations and experiments in the various application sectors, for descriptive, interpretative and decision-making purposes. It includes the theoretical and methodological developments of descriptive, exploratory and inferential statistics in their various articulations such as mathematical statistics, sample theory, experiment planning, statistical analysis of multivariate data, statistical analysis of time and space series.
The verification methods will evaluate that the student has acquired the skills in setting up experimental plans and in the statistical evaluation of the results.
ADVANCED PHARMACOLOGY – (6 ECTS)
The purpose of the course is to guide the students through the main factors regulating the passage of molecules within the body and their effect via interaction/modulation of molecular endogenous cascades. Specifically, the pharmacokinetics will be addressed to: general principles (ADME - absorption, distribution, metabolism and elimination, plasma concentration/time curves); main pharmacokinetic parameters and development of the mathematical model (calculation of the pharmacokinetic parameters - Cp, Vd, AUC, Kel, half-life, CL); hepatic and renal metabolism and elimination.
Pharmacodynamics will be focused on: mechanism of action (proteins as binding targets); concept of potency, efficacy, and affinity; concept of agonist, antagonist, and partial agonist; different types of receptors and related signal transduction mechanisms; examples of molecular cascades; selective targeting of nanoparticles in order to increase the efficacy and safety; various types of nano-formulations for drug delivery and relative in vitro characterization and analysis.
The methods of verification will be addressed to evaluate the understanding by students of the pharmacokinetic fate of the nanoparticle systems and their interaction with the biological targets.
INDUSTRIALIZATION – (9 ECTS) 2 modules
INDUSTRIALIZATION AND REGULATORY ASPECTS – (6 ECTS)
The aim of the course is to focus on the transition from the therapeutic idea and formulation development to the production process. The following topics will then be covered.
The choice of nanotechnology: strategic and technological aspects. The main preparation techniques of nanosystems: top-down and bottom-up methods. Consolidated technologies (liposomes, nanocrystals, solid lipid nanoparticles, complexes), laboratory methods and scalable manufacturing techniques such as microfluidics, electrospinning, 3Dprinting. Methods of physical-chemical characterization of nanosystems for registration purposes. Process validation and validation of analytical methods. The European and international regulatory scenario and the registration dossier with particular reference to quality. Comparability studies and nanosimilars.
The verification methods will be designed to verify that the student has acquired the skills necessary for the industrial development and registration of nanoparticle systems with reference to the European guidelines.
ANALYTICAL METHODS IN NANOMEDICINE (3 ECTS )
Aim of the course is to provide knowledge and skills on the separation techniques for the analysis of small molecules as well as protein macromolecules of pharmaceutical interest, within the European regulatory framework, with particular reference to method validation, specifications, stability (ICH guidelines). For each method the theoretical principles and the main applications in biotechnology and nanomaterials will be evaluated.
The final exam will verify that the student has acquired the skills in the analytical-pharmaceutical field, suitable for the characterization of biomolecules and nanoparticle systems.
EXPERIMENTAL PHARMACOLOGY (3 ECTS) free choice course
The aim of the course is to provide the knowledge and the skills on the principles and, in general, on the biological experimental methods useful for studying molecules with pharmacological activity.
In particular, the course of experimental pharmacology aims to guide the students through the bases of an experimental approach for evaluating the qualitative and quantitative biological responses. In detail, the student will acquire skills in: experimental setting; biological parameters and units of measurement; examples of in vitro methods and techniques (cell cultures, cell viability assays and microscopy investigations); evaluation of the results, statistical analysis and discussion.
The methods of verification will evaluate the acquisition of these skills.
SPECIFIC APPLICATIONS OF INORGANIC NANOMEDICINES – (3 ECTS) free choice course
The aim of the course is to highlight the chemical-physical features that differentiate inorganic nanoparticles from lipidic, polymeric, liposomal ones, in relation to their use in nanomedicine. Specific examples of inorganic nanosystems in clinical use, such as superparamagnetic iron oxide nanoparticles (MRI contrast media), or in clinical trials, such as Cornell dots (fluorescent silica biomarkers) will then be illustrated. The course will also deal with inorganic nanoparticles currently under academic study both for drug delivery and for photothermal anticancer therapies (non-spherical gold nanoparticles, Prussian Blue nanocubes). Finally, medical devices based on antimicrobial inorganic nanomaterials (silver, copper) will be illustrated, also in relation to their use to limit the spread by contact of bacterial and viral infections.
The exam modality will be aimed at verifying that the student has acquired the knowledge relating to thr specific nanoparticle systems illustrated in the course
SPECIFIC APPLICATIONS OF NANOMEDICINES - (3 ECTS) free choice course
The aim of the course is to deepen the knowledge related to the following aspects:
- Site specific applications of nanosystems. Thermogelling systems and mucoadhesion. Pulmonary, nasal, ocular, cutaneous and dermal/transdermal applications. Drug targeting - drug targeting using nanosystems. Passive and active targeting. Particle systems sensitive to internal and external chemical and physical stimuli. Drug targeting and cancer therapy. Nanoncology.
- Nanoparticulate systems for diagnostic and theranostic. Nanotechnology in vaccine development.
Mucosal vaccination. Nanotechnologies to overcome blood brain barrier. Nanomaterials and their use in medical device and cosmetic fields. Nanotechnologies for the conveyance of substances of vegetable origin.
The verification methods will be aimed at verifying that the student has acquired the knowledge relating to the nanoparticle systems described and their specific applications.