SFKK18003U  Principles and Practice of Bioanalysis

Volume 2018/2019
Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme)- elective 

MSc Programme in Environmental Science (SCIENCE) - restricted elective

Content

The course is intended for (a) students specializing in bioanalysis (determination of pharmaceuticals in biological fluids), and for (b) students with need for improved general knowledge and skills in analytical chemistry / pharmaceutical chemical analysis. The latter students are typically master students using analytical techniques during the experimental work for the master thesis. The course focuses both on theoretical and practical aspects of bioanalysis.

The first part of the course teaches the principles of major bioanalytical techniques at high level (lectures):

  • Sample preparation (protein precipitation, liquid extraction, solid-phase extraction)
  • Liquid chromatography
  • Liquid chromatography-mass spectrometry
  • Gas chromatography
  • Gas chromatography-mass spectrometry
  • Capillary electrophoresis

The second part of the course teaches the use of the above techniques at high level for the following purposes (lectures):

  • Determination of small molecule pharmaceuticals in biological fluids (blood, urine, saliva, dried blood spots)
  • Determination of biopharmaceuticals in biological fluids
  • In-vitro metabolism studies of small molecule pharmaceuticals

Application areas include therapeutic drug monitoring, in-vitro metabolism studies, forensic toxicology, and doping analysis.

The third part of the course focus on reading and understanding research articles in bioanalysis related to the techniques and applications outlined above, and include student presentation of selected articles.

The fourth part of the course comprises laboratory exercises related to the techniques and applications outlined above.

Learning Outcome

At the end of the course, students are expected to be able to:

Knowledge

  • Have an in-depth theoretical understanding of the major techniques used in bioanalysis of pharmaceuticals
  • Understand the individual steps in procedures for determination of small molecule pharmaceuticals and biopharmaceuticals in biological fluids
  • Understand the individual steps of in-vitro metabolism studies of small molecule pharmaceuticals

Skill

  • Be able to perform practical bioanalytical work according to published / existing procedures
  • Know and be able to use a broad number of separation and detection principles as well as sample preparation techniques used for bioanalysis.
  • Understand the principles behind and use the analytical chemical instrumentation needed for high sensitivity analysis of samples of biological origin.
  • Judge and use the relevant original analytical chemical literature, handbooks and databases.

Competence

  • Understand and perform bioanalytical chemical work.
  • Develop new analytical chemical methods for analysis of samples of biological origin (e.g. urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
  • Design sampling and storage protocols for in vivo studies of drug substances.
  • Steen Honore Hansen, Stig Pedersen-Bjergaard: Bioanalysis of Pharmaceuticals: Sample Preparation, Chromatography and Mass Spectrometry, ISBN: 978-1-118-71682-3, Wiley (2015)
  • Additional course materials such as manuals and scientific papers are availabe from the course homepage
Course teaching is based upon the assumption that the student has acquired basic skills in instrumental analytical chemistry corresponding to at least a 7.5 ECTS course at bachelor level. In addition general knowledge within the areas of organic chemistry, inorganic chemistry, physical chemistry, analytical chemistry, biochemistry, pharmacology, toxicology, and drug development at bachelor level is expected.
Lectures: 32 hours
Laboratory exercises: 24 hours
In order to be able to take the exam the oral presentation of the "Independent Study Activity" must be approved and the student must have completed all the laboratory exercises.
Oral
Collective
Credit
7,5 ECTS
Type of assessment
Written examination, 2 timer under invigilation
Examination type:
2 hour multiple-choice test.

Examination design:
The multiple choice-test is made up of a number of statements (typically 50) to which the student has to decide whether they are true or false.
Aid
Written aids allowed

There is access to the following at the exam on Peter Bangs Vej:

  • Office (Word, Excel, Onenote and Powerpoint)
  • IO2 – the digital pen
  • Panoramic Viewer
  • Paint
  • Calculator – Windows' own
  • R – Statistical programme
  • ITX MC – multiple choice programme
  • Adobe reader
  • ChemDraw
  • MathType formel programme
  • Maple
  • USB access – for usb stick with notes etc.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To pass the course the student must be able to:

Knowledge

  • Have an in-depth theoretical understanding of the major techniques used in bioanalysis of pharmaceuticals
  • Understand the individual steps in procedures for determination of small molecule pharmaceuticals and biopharmaceuticals in biological fluids
  • Understand the individual steps of in-vitro metabolism studies of small molecule pharmaceuticals

Skill

  • Be able to perform practical bioanalytical work according to published / existing procedures
  • Know and be able to use a broad number of separation and detection principles as well as sample preparation techniques used for bioanalysis.
  • Understand the principles behind and use the analytical chemical instrumentation needed for high sensitivity analysis of samples of biological origin.
  • Judge and use the relevant original analytical chemical literature, handbooks and databases.

Competence

  • Understand and perform bioanalytical chemical work.
  • Develop new analytical chemical methods for analysis of samples of biological origin (e.g. urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
  • Design sampling and storage protocols for in vivo studies of drug substances.

Students are evaluated from the participation in the laboratory exercises as well as from the multiple choice examination and their "Independent Study Activity" where they critically present analytical chemical literature.

  • Category
  • Hours
  • Lectures
  • 32
  • Preparation
  • 150
  • Practical exercises
  • 24
  • Total
  • 206