General provisions

The course can be part of the Master of Science in Pharmacy programme, the Master's Programme in Chemical Engineering or the Master's Programme in Biopharmaceuticals. The course is given within the Master's Programme in Pharmaceutical Modelling and the Master's Programme in Drug Discovery and Development.

Entry requirements

150 credits, including 120 credits in biomedicine, pharmaceutical sciences and/or natural sciences/engineering. Previous studies must include 3 credits of pharmaceutics and pharmacokinetics.

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

Learning outcomes

After having completed the course, the student should be able to

• describe the role of biopharmaceutics in drug development within the pharmaceutical industry 
• explain biopharmaceutical, physiological, biochemical and cell biology aspects of drug transport and metabolism in the gastrointestinal tract and liver.
• analyse the drug transport and metabolism mechanisms of importance for drug-drug interactions under specific conditions (effect of polypharmacy, food intake and population kinetics).
• describe and apply computational and experimental methods to study drug transport and metabolism and interactions.
• explain regulatory requirements within the biopharmaceutical field.
• plan, compile, analyse and present experiments, as well as critically read and, analyse scientific literature of relevance to biopharmaceutics.
• explain regulatory requirements within the biopharmaceutical field.
• reflect upon and orally present scientific literature

Content

Physiological, biochemical and cellbiological background to the gastrointestinal tract and liver, and how these can be related to drug transport and metabolism.

Basic understanding of methods used to study dissolution, permeability, transit time, stability, metabolism and physiology-based pharmacokinetics (PBPK). These include in silico, in vitro, in situ and in vivo methods used to elucidate possibilities and limitations in predictions of biopharmaceutical processes in humans.

Mechanistical insights to cellular transport processes and metabolism are provided to understand molecular features of importance for drug transport and clearance. Drug-drug interactions and interactions with food and the relevance of such interactions for intestinal drug absorption, liver distribution and extraction.

Overview of principles to formulate different types of problematic drug molecules and when other administration routes than the oral are suitable.

Regulatory aspects on drug absorption, bioavailability and bioequivalence based on guidelines from e.g. FDA, and EMA.

Instruction

The teaching is based on lectures, seminars, group exercises, laboratory work and a literature study. Some sessions may be given digitally.

Compulsory sections: seminars, group exercises, laboratory work, literature study.

Assessment

A combined oral and written examination is performed at the end of the course. In addition to the combined oral and written exam (6 credits), passing the course requires the grade pass on the literature study (0.5 credits), laboratory work (0.5 credits) and mandatory seminars and group exercises (0.5 credits).

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 regulations

Replaces the course Biopharmaceutics 3FG820 and cannot be included in the same degree as this one due to overlap.

Replaces and corresponds to Molecular biopharmacy 3FG880.