General provisions

Equal to the former courses 3FK063 Pharmaceutical and Biomedical Analysis and 3FK308 Pharmaceutical and Biomedical Analysis and cannot be included in a higher education qualification together with these courses.

This course substitutes and corresponds to 3FK328.

Entry requirements

For students in the Pharmacy programme, it is required that the student should have achieved 150 credits within the programme, including Analytical Pharmaceutical Chemistry, Bioanalytical Chemistry and Product and Process Analytical Chemistry as well as having followed all earlier courses on semester 1-7.

For students in the Engineering programme, it is required that all chemistry courses in the programme from years 1-2 and the course Analytical Chemistry in Drug Development 15 credits should have been taken.

For students within the Master programme in drug development it is required that Product and Process Analytical Chemistry or Product and Process Analytical Chemistry in Drug Development has been taken.

Qualified to be accepted to a freestanding course are those that have 150 credits including knowledge equivalent to 60 credits chemistry including Analytical Pharmaceutical Chemistry, Bioanalytical Chemistry and Product and Process Analytical Chemistry. Knowledge in English equivalent to what is required for basic entry to Swedish higher education.

Learning outcomes

On completion of the course, the student will be able to

\x{2022} Search relevant literature and establish an experimental design for an analytical pharmaceutical method.

\x{2022} Carry out a risk assessment for laboratory work.

\x{2022} From a compiled experimental design independently develop and validate an analytical pharmaceutical method and document this in a scientific and quality assured way.

\x{2022} Present achieved results in the form of a scientific article written in English.

\x{2022} Present and defend achieved results orally.

\x{2022} Publicly discuss an other student's written and oral presentation.

Content

Sampling and sample pretreatment. Advanced separation theory for chromatographic and capillary electrophoretic techniques. Applied mass spectroscopy. Method construction and optimisation. Quality assurance. Regulatory aspects on drug analysis. Literature search. Research documentation. Critical review of scientific articles.

Instruction

The teaching is given in the form of seminars, study visits and laboratory work on method development. Strong emphasis is placed at the students' own learning and ability to seek information independently and to solve problems.

Compulsory parts of the course: seminars and all phases in connection with the laboratory practical.

Assessment

Examination takes place at the end of the course in the form of an oral and a written presentation of the laboratory practical (examination code).

Supplementation of failed compulsory parts can at the earliest take place at next course and then in case of a vacancy.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Other directives

The course is given in English, when coordination takes place with exchange students.