Quantitative Bioanalysis

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Faculteit Science and Engineering
Jaar 2018/19
Vakcode WMFA14005
Vaknaam Quantitative Bioanalysis
Niveau(s) master
Voertaal Engels
Periode semester II a
Rooster rooster.rug.nl

Uitgebreide vaknaam Quantitative Bioanalysis
Leerdoelen To gain insight in the role of bioanalysis in drug research.
After following the course, the participants will have a good working knowledge of the different contemporary techniques for quantitative bioanalysis.
Omschrijving 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 the industrial 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 following aspects of quantitative bioanalysis will be covered:
• 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
Uren per week
Onderwijsvorm Bijeenkomst (S)
(Lectures (38 hours), tutorials (12 hours), questions and answers (3 hours), excursion (8 hours), self-study)
Toetsvorm Schriftelijk tentamen (WE)
Vaksoort master
Coördinator prof. dr. N.C. van de Merbel
Docent(en) prof. dr. R.P.H. Bischoff , Guest Lecturer(s) ,dr. H.P. Permentier ,prof. dr. N.C. van de Merbel
Verplichte literatuur
Titel Auteur ISBN Prijs
powerpoint files, will be made available electronically
Opmerkingen Group size: at least 6 and no more than 20 participants.

The course will be given by several experts from academia and industry. An excursion to an industrial bioanalytical laboratory is part of the course.
Guest lecturers:
Dr. G. Hendriks
Dr. F.H. van Heuveln
Dr. M. Nemansky
Dr. A. Roffel
Dr. B.W.A. van der Strate
Opgenomen in
Opleiding Jaar Periode Type
MSc Farmacie keuzevakken - semester II a keuze
MSc Medical Pharmaceutical Sciences: Spec. Medical Pharmaceutical Sc. research  (Electives) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Spec. Pharmaceutical Design and Engineering  ( Suggest Electives) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Spec. Science, Business and Policy  (Electives (10 ECTS)) - semester II a keuze
MSc Medical Pharmaceutical Sciences: track Pharmaco-epidemiology  (Other possible Electives) - semester II a keuze
MSc Medical Pharmaceutical Sciences: track Toxicology and Drug Disposition  (Electives ) - semester II a keuze