Analytical methods in drug discovery and development and validation of analytical procedures in pharmaceutical industry

A.Y. 2020/2021
8
Max ECTS
64
Overall hours
SSD
CHIM/08
Language
Italian
Learning objectives
The main objective of the course is to illustrate and discuss the most important analytical approaches used in the different stages of the process of research, development and production of drugs. In particular, the course involves the transfer of knowledge of the most modern analytical approaches used in the research and development process and in particular: a) to identify and validate the therapeutic targets; b) to define the mechanism of action of the molecules identified with phenotypic approaches; c) to identify the target compounds; d) to characterize the molecular interactions ligand-target; e) to identify and optimize the lead compounds. The course also includes training on the analytical aspects used in industry for the processes development not only of small molecules but also of large molecules and phyto-derived products.
In line with its concept of professionalizing course, the course aims therefore not only to transfer to the student the most modern knowledge in pharmaceutical analysis, but also to provide the tools needed to develop a critical approach necessary to address the analytical issues in the field of research, development and production of the drug.
Expected learning outcomes
At the end of the learning process the student must know the most important analytical applications used in the processes of research, development and production of the drug. The student must also understand the main analytical problems and design possible solutions applying not only the knowledge acquired during the course but also that obtained in the modules of advanced methodologies in pharmaceutical chemistry.
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
Lessons are held on line in synchronous mode remotely following the timetable and using the Teams platform.
The exam consists of an oral test on Teams platform . The evaluation of the exam is out of thirty.
In order to be able to take the examination, it is essential to register for the exam session through the online SIFA service of the University. The outcome of the exam will be given at the end of the oral exam.
Prerequisites for admission
Knowledge of pharmaceutical and analytical chemistry.
Assessment methods and Criteria
The exam consists of an oral test which is related to the topics covered in class, and is articulated in four open-ended questions with a final grade out of thirty. The test lasts 30 minutes.
In order to be able to take the examination, it is essential to register for the exam session through the online SIFA service of the University.
Analytical methods in drug discovery and development
Course syllabus
- Introduction to the course: the role of pharmaceutical analysis in the drug discovery, development and production process;
- Analysis of biomacromolecules using mono- and bi-dimensional NMR, X-rays and mass spectrometry;
- Identification of the drug target: affinity methods and chemoproteomic analysis;
- Identification of target compounds: analytical methodologies for the study of target-ligand interaction (NMR, X-rays, mass spectrometry, surface plasmonic resonance, calorimetric and fluorimetric methods); High-throughput screening (HTS) methods for the screening of libraries;
- Identification of lead compounds and their optimization: analytical approaches in mass spectrometry, analytical methods for pre-ADMET studies and for the prediction of idiosyncratic reactions; analytical methods for the characterization of the thermodynamic and kinetic properties of the target-ligand complex;
- Analytical methods in the pre-clinical and clinical phase: analytical and bioanalytical methods for the identification, characterisation and quantisation of metabolites and for pharmacokinetic studies (ADMET studies);
Teaching methods
Lessons are held on line in synchronous mode remotely
Teaching Resources
All the teaching material presented during the lessons (constituting the topics of the exam) is made available in pdf format on the Ariel portal of Unimi.
Instrumental analysis and validation of the analytical procedures in pharmaceutical industry
Course syllabus
- Development and validation of new analytical methods, good laboratory practices, stability studies, control of raw materials and finished pharmaceutical products, drafting of drug master files;
- Instrumental analysis and quality control of small molecules;
- Instrumental analysis and quality control of extracts and plant derivatives;
- Instrumental analysis and quality control of biopharmaceuticals;
- Instrumental analysis and quality control in the cosmetic industry.
Teaching methods
Lessons are held on line in synchronous mode remotely
Teaching Resources
All the teaching material presented during the lessons (constituting the topics of the exam) is made available in pdf format on the Ariel portal of Unimi.
Analytical methods in drug discovery and development
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 4
Lessons: 32 hours
Instrumental analysis and validation of the analytical procedures in pharmaceutical industry
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor(s)