Entry requirements

150 credits which of 120 credits in biomedicine, biology, pharmaceutical science, chemistry and/or science/engineering. Prior studies should contain 5 credits in pharmacokinetics and 7.5 credits in pharmacology.

Proficiency in English equivalent to the Swedish upper secondary course English 6.

Learning outcomes

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

• Explain principles for absorption, 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 therapeutic antibodies such as monoclonal antibodies (mAbs) and antibody fragments, bispecific antibodies, and antibody conjugates, but also covers other types of biologics such as peptides, oligonucleotides, hormones, enzymes, and cell therapies. The course includes PKPD with a focus on mAbs and other biologicals, translation from preclinic to clinic and clinical drug development, therapeutic area-specific aspects and biosimilars.

Instruction

The main part of the work takes place in groups. The teaching consists of lectures, workshops, and demonstrations/exercises with software. Each workshop has an assignment that is reported jointly in a group or presented in writing individually. 

Mandatory elements: Active participation in workshops.

The course is given in English.

Assessment

The course combines continuous oral and written examinations with a written exam at the end of the course. In addition to the written exam (2,5 credits), a completion of PKPD with focus on mAbs (1 credit), other biological drugs (1 credit), translation from preclinical to clinical and clinical drug development (2 credits), therapeutic area-specific aspects (0,5 credits), and biosimilars (0,5 credits) is required for a passing grade in the course.

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.