Entry requirements

Entry requirements:

The programme in Master of Science in Pharmacy: at least 150 credits within the programme including passed courses in pharmacokinetics 7.5 credits, pharmacology and physiology. Furthermore, registration at all earlier courses within the pharmacy program is required

The programme in Master of Science in Chemical Engineering: at least 150 credits within the programme is required, and courses corresponding to Pharmacokinetics 7.5 credits, Physiology 6 credits and Pharmacology 7.5 credits

Master Programme in Biological drugs: admitted and complied prior courses within the program

Master Programme in Drug Discovery and Development: admitted and complied prior courses within the program

Master Programme in Pharmaceutical Modelling: admitted and complied prior courses within the program

Acceptance to a single subject course requires a) basic qualification according to the higher education ordinance (150 credits), and b) knowledge corresponding to 60 credits within the subject Pharmacy, Pharmaceutical science, or Pharmaceutical bioscience, including Pharmacokinetics 7.5 credits, and c) knowledge corresponding to Physiology 6 credits and Pharmacology 7.5 credits

Learning outcomes

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

• Explain principles for distribution and elimination of different types of biological drugs and their relation to desired and unwanted effects
• Interpret results from pharmacokinetic-pharmacodynamic (PKPD) studies of monoclonal antibodies
• Describe challenges specific to characterize pharmacokinetics and pharmacodynamics (PKPD) for biological drugs in different therapeutic areas
• Plan and motivate the design of clinical trials of biological drugs based on pharmacokinetic and pharmacodynamic (PKPD) aspects
• Identify PKPD properties of relevance to biosimilars
• Summarize and structure results from a scientific literature review
• Communicate scientific results for both lay people and expert groups in proper English
• Argue for a PKPD-related hypothesis based on scientific documentation

Content

The course provides a detailed view of PK and PD properties for different biological drugs and illustrates how these properties affect both drug development and use. The course focuses on protein drugs, especially monoclonal antibodies, but also covers other types of biological drugs such as peptides, oligonucleotides, bispecific antibodies, antibody conjugates, hormones, enzymes, vaccines and cell therapies. The course is divided into five modules that include PK (PD) with a focus on mAbs (1 credits) and other biological drugs (1 credits), therapy area-specific aspects (0.5 credits), translation from preclinic to clinic and clinical drug development (2 credits) and biosimilars (0.5 credits).

Instruction

The main part of the work takes place in groups. The teaching consists of lectures, workshops, and demonstrations/exercises with software. Each workshop is a larger assignment that is reported joint in groups or presented in writing individually. Compulsory parts of the course: Active participation in workshops.

Assessment

The course uses a combination of continuous examinations and a written final exam. The course is divided into five modules that are examined through oral presentations (2 as 0.5 hp, 2 as 1 hp) as well as oral and written assignment (1 as 2 hp). The written exam is credited with 2.5 hp.

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 disability coordinator of the university. Re-examination is organised when necessary.