General provisions

Substituting and corresponding earlier the course 3FG420 Biopharmaceutics. 1.5 credits (hp) correspond to 1 credit point (p) according to earlier study regulation.

Entry requirements

For search within: - the Master of Science Programme in Pharmacy the student should have 150 credits (100 credit points) within the programme of which 60 credits (40 credit points) pharmacy including programme course in pharmaceutics and pharmacokinetics and have followed all earlier courses within the programme. - the Bachelor of Science Programme in Pharmacy the student should have at least 120 credits (80 credit points) within the programme of which 60 credits (40 credit points) pharmacy including programme course in pharmaceutics and pharmacokinetics and have followed all earlier courses within the programme. - the chemical engineering programme the student should have at least 120 credits (80 credit points) including programme course in pharmaceutics and pharmacokinetics. For single subject course, 150 credits (100 credit points) are required of which knowledge equivalent 60 credits (40 credit points) pharmacy including basic education in pharmaceutics and pharmacokinetics. Other education is tested individually. Knowledge in Swedish and English equivalent what that is required for basic eligibility to Swedish higher education on basic level.

Learning outcomes

The students should on completion of the course: - be able to explain biopharmaceutical, physiological, biochemical and cell biology-related aspects on the transport and metabolism of drugs in the gastrointestinal tract and in the liver - be able to explain mechanisms behind the transport of drug and metabolism and how drugs can interact with other drugs and food and methods to study these - having developed its ability to plan, compile, analyse and report experiment that has importance for biopharmaceutical issues - be able to account for regulatory requirements within the biopharmaceutical area - be able to describe the role of biopharmaceutics in drug development within the pharmaceutical industry

Content

Physiological, biochemical and cell biology-related background to the physiology of the gastrointestinal tract and the liver and how it relate to the transport and metabolism of drug. It is also included to obtain a certain understanding of how different pathophysiological processes can influence the function as regards transport and metabolism of drugs of the gastrointestinal tract and the liver. Basic understanding of which methods that have been used to study dissolution, permeability, transit times, stability and metabolism. This includes in silico, in vitro, in situ and in vivo methods. Of great importance is to understand possibilities and limitations to predict biopharmaceutical processes in man. An increased mechanistic understanding of how a drug can interact with an other drug and how food can influence drugs absorption from the intestine and the transport through the liver. Go through which principles that are to be able to achieve an optimum oral dosage form at various types of "problemdrugs". Regulatory aspects on the absorption, bioavailability and bioequivalence of drug. We work from "guidelines" from for example FDA and EMEA. A part of the course will also contain aspects on how and when other routes of drug administration are appropriate to use.

Instruction

The teaching is given as lectures, seminars, group exercises, laboratory sessions, literary work. Compulsory parts of the course: Course introduction, group exercises, laboratory sessions and literary work.

Assessment

Examination takes place at the end of the course. To pass the course is required apart from passed examination (examination code), passed results of literary work (examination code) and laboratory sessions and other compulsory parts (examination code). Possibility to supplement failed compulsory part can be given at the earliest at next course and only in case of a vacancy. Each student has the right to in all six examinations i.e. one examination and five re-examinations.