Learning outcomes

After having completed the course, the student should

• understand the role of biopharmaceutics in the drug discovery and development process.
• be able to explain biopharmaceutical, physiological, biochemical and cellbiological aspects on drug transport and metabolism in the gastrointestinal tract and liver.
• be able to analyse the drug transport and metabolism mechanisms of importance for drug-drug interactions under given circumstances (effect of fed state, medications and impact on certain population groups).
• be knowledgeable about and able to apply computational and experimental methods to study these processes and interactions.
• be able to explain regulatory demands of importance for biopharmaceutical evaluation.
• be able to plan, compile, analyse and present experiments, as well as critically read, analyse and present scientific papers of relevance to biopharmaeceutics.
• explain regulatory demands of importance for biopharmaceutical evaluation.

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 the regulatory authorities (e.g. FDA, EMA).

Instruction

The teaching is based on lectures, seminars, exercises, computational and experimental laboratory work and a literature study. The course is given in Swedish or English.

Compulsory sections: course start, exercises, laboratory work, literature study.

Assessment

Examination is performed at the end of the course. In addition, passing the course requires presence during compulsory sections of the course and approved examination of laboratory work and literature study. Possibility to redo or complement compulsory sections can earliest be provided the next semester in case of vacancies. Students have right to six examinations, i.e. one examination and five re-examinations.