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.