Syllabus for Molecular Biopharmaceutics

Decisions and guidelines

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

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 drug transport and metabolism 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.
• developed tha ability to 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 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.

Compulsory sections: 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.

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

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.