Bioanalyses

Description of the latest mass spectrometry techniques for analyses in the pharmaceutical industry (drug development: drug discovery and preclinical analyses).

Mass spectrometry instrumentation and data acquisition methods in the pharmaceutical industry for the following applications:

• Analyses at the various stages of drug development,
• Qualitative metabolic analyses,
• Quantitative Analyses in Pharmacokinetics.

Hourly Volumes*:

            CM: 3:00 p.m.

           Land: 5 H

Be able to determine the analytical protocol for quantifying small organic molecules using mass spectrometry.

Understand and be able to analyze a series of assays to quantify an organic compound in a complex sample.

Understanding the implementation of analyses in the pharmaceutical industry.

Mass Spectrometry, Level M1:           

Advanced concepts (generation and measurement of ions in the gas phase, ionization, analyzers, and vibrational activation; technologies featuring MS/MS analyzer configurations).

Separation Methods, M1 Level:  

Knowledge of the various types of liquid chromatography

2-hour final written exam:

• Authorized documents: No
• Non-graphical calculators allowed: yes
• Internet access allowed: No

Course: Inductive (problem-based) and deductive pedagogy. Materials available on the digital learning platform (Moodle): Course materials, tutorial materials, past exam questions, and reference publications.

1. Analysis in the Pharmaceutical Industry: (5 hours)

• LC/MS and LC/MS/MS analyses at various stages of drug development,
• ADME profile and metabolic pathways (pharmacokinetic analyses),
• Regulatory Concepts and GLP Standards.

1. Qualitative Analysis by Mass Spectrometry: (5 H)

• Study of metabolism,
• Instrumentation (LC/HR-MS/MS).

1. Targeted quantitative analysis by mass spectrometry: (5 H)

• Isotopic dilution and calibration,
• Instrumentation (LC/MS/MS(QqQ),
• Analytical Protocol (MRM Monitoring and Assay Method),
• Concepts of method validation.

Fieldwork (5 H): 1 practical session on research tools.

Illustration of the quantification of an active ingredient or compound of interest using MRM analysis. (1 session)