Bioassays

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

Instrumentation and acquisition modes in mass spectrometry in the pharmaceutical industry for the following applications:

• Analyses at various stages of drug development,
• Qualitative analyses in metabolism,
• Quantitative pharmacokinetic analyses.

Hourly volumes*:

            CM: 3 p.m.

           Land: 5 H

Be able to determine the analytical protocol for performing assays of small organic molecules by 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 analytics in the pharmaceutical industry.

Mass spectrometry, M1 level:           

Advanced concepts (gas phase ion production/measurement, ionization, analyzer and vibrational activation, technologies featuring MS/MS mode analyzer configurations).

Separative Methods, M1 level:  

Knowledge of various types of liquid chromatography

2-hour final written exam:

• Authorized documents: no
• Non-graphing calculator permitted: yes
• Internet access: no

Course: Inductive (problem-based) and deductive teaching methods, Materials available on the digital workspace (Moodle): Course documents, tutorial documents, past exam papers, and reference publications.

1. Analysis in the pharmaceutical industry: (5 hours)

• LC/MS and LC/MS/MS analyses in the various stages of drug development,
• ADME profile and metabolic pathways (pharmacokinetic analyses),
• Concepts of regulations 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 hours): 1 practical session on research tools.

Illustration of the dosage of an active ingredient/compound of interest through the implementation of MRM monitoring. (1 session)