Bioanalysis

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

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

• Analyses in the various stages of drug development,
• Qualitative analysis in metabolism,
• Quantitative analyses in pharmacokinetics.

Hourly volumes* :

            CM : 15 H

           Field : 5 H

Be able to determine the analytical protocol to perform small organic molecule assays by mass spectrometry.

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

Understand the implementation of analyses in the pharmaceutical industry.

Mass spectrometry, level M1:           

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 the various types of liquid chromatography

Final written exam of 2 hours:

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

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

1. Analysis in the pharmaceutical industry: (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 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 determination method),
• Notions of method validation.

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

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