Course: Quantitative Bioanalysis

Bioanalysis refers to the analysis of biological samples, i.e. fluids and tissues obtained from living organisms such as animals and humans. In quantitative bioanalysis, the concentrations are determined of all kinds of molecules in biological samples. As such, it is very important for pharmaceutical and medical research, because many conclusions about the state of health of a person and about the efficacy and safety of pharmaceutical treatment are based on the concentrations of drugs and of endogenous compounds (or biomarkers) in body fluids.

 

This course discusses the quantitative aspects of bioanalysis. The focus will be on the role of quantitative bioanalysis in research and development of new drugs, but the information has a broader applicability to other types of pharmaceutical and medical research. Recently, there have been many developments in the field of quantitative bioanalysis, both with regard to the technologies used and with regard to regulatory aspects, i.e. the procedures that are applied to ensure the scientific reliability of the results. The course will give an in-depth overview of all these issues, covering both theoretical and practical aspects. Case studies will be presented to illustrate the importance of a proper scientific approach.

 

The course will be given by several experts from academia and industry. An excursion to an industrial bioanalytical laboratory is part of the course. The following aspects of quantitative bioanalysis will be covered:

General:

• The role of bioanalysis in drug development
• The bioanalytical support of preclinical and clinical trials

Technology (small molecules):

• A historical overview of technological developments
• Sample preparation
• Chromatography (LC)
• Mass spectrometry (MS)
• The role of drug metabolism in bioanalysis
• Application of LC-MS in practice

Technology (macromolecules):

• Binding assays
• Pharmacokinetic and pharmacodynamic applications and their correlation
• Immunogenicity assays
• LC-MS for macromolecules

Regulatory aspects:

• Validation and quality control
• Good laboratory practice

Specific applications:

 

• Biomarker discovery
• Dried blood spots
• Inductively coupled plasma (ICP) MS
• Flow cytometry

 

After following the course, the participants will have a good working knowledge of the different contemporary techniques for quantitative bioanalysis. The course will be completed with a written exam.

Due to the Corona virus, there will be no course in 2021. 

EC (with exam)

5

Course coordinator

• prof. N.C. van de Merbel
  

Language

English

Contact person

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