Bioanalysis

Description of the latest mass spectrometry techniques for analyses in the pharmaceutical industry (drug development : Drug discovery and pre-clinical analysis).

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

• Analysis in the various stages of drug development,
• Qualitative metabolic analysis,
• Quantitative pharmacokinetic analyses.

Hourly volumes* :

            CM: 15 H

           Field : 5 H

Be able to determine the analytical protocol for the mass spectrometric determination of small organic molecules.

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

Understand how analyses are carried out in the pharmaceutical industry.

Mass spectrometry, level M1 :           

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

Separative Methods, level M1 :  

Knowledge of the various types of liquid chromatography

Final written exam, 2 hours:

• Authorized documents: no
• Non-graphic calculator allowed: yes
• Internet allowed: no

Course: Inductive (problem-based) and deductive pedagogy, Support(s) available on ENT (Moodle): Course documents, TD documents, exam annals and reference publications.

1. Pharmaceutical industry analysis: (5 H)

• LC/MS and LC/MS/MS analyses in the various stages of drug development,
• ADME profile and metabolic pathways (pharmacokinetic analyses),
• Notions of GLP regulations and 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)

• Isotope dilution and calibration,
• Instrumentation (LC/MS/MS(QqQ)),
• Analytical protocol (MRM monitoring and dosing method),
• Notions of method validation.

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

Illustration of an assay for an active ingredient/compound of interest using MRM monitoring. (1 session)