EPN

FARB2100 Biopharmaceutics and Pharmaceutical Science Course description

Course name in Norwegian
Biofarmasi og legemiddelformulering
Study programme
Bachelorstudium i farmasi - reseptarutdanning
Weight
10.0 ECTS
Year of study
2021/2022
Schedule
Course history

Introduction

This course focuses on the characteristic properties of different types of active ingredients, formulations and routes of administration, as well as theory on and practical presentation of sterile pharmaceutical production.

Required preliminary courses

The student must have passed the first year of the programme or equivalent.

Learning outcomes

After completing the course, the student should have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

  • can describe the structure and function of biological barriers
  • can explain the function of relevant ancillary substances in pharmaceutical preparations
  • is capable of explaining factors that can limit the bioavailability of active ingredients and influence the biopharmaceutical properties of pharmaceuticals
  • can explain the choice of active ingredients, formulation and route of administration in connection with pharmaceutical development
  • can give grounds for how the durability and conditions for storage of pharmaceuticals are determined
  • is capable of assessing the use of different pharmaceutical formulations based on a patient’s condition and needs

Skills

The student

  • can discuss principles of pharmaceutical formulation based on information from summaries of product characteristics (SPC) and any other relevant pharmaceutical reference works
  • masters basic skills in aseptic work technique and sterilisation procedures
  • can assess whether a pharmaceutical batch is consistent with specific quality requirements
  • can present an allocated relevant topic to fellow students

General competence

The student

  • can apply knowledge to identify innovative formulations and critical stages of the development and production of pharmaceuticals
  • can familiarise him/herself with the principles of formulation for new pharmaceuticals
  • can assess possibilities for individual adaptation of pharmaceutical formulation to create the best possible health at the individual level
  • has a conscious relationship to the choice of own formulation and routes of administration
  • has an understanding of the role of the pharmacist in pharmaceutical development and production

Content

Subjects covered by the course, with credits specified:

  • Biopharmaceutics and pharmaceutical science 10 credits

Teaching and learning methods

Work and teaching methods include lectures, group work, question sessions and laboratory work. The lectures involve student activity and the material elucidated with the help of examples of clinical relevance. The laboratory work focuses on aseptic work technique. The flipped classroom method is used for parts of the course. Digital learning resources will be made available to students in advance, and the time they spend at the university will be used to work on assignments and group work.

Course requirements

The following must have been approved in order for the student to take the exam:

  • Minimum attendance of 90% in the laboratory course in the production of pharmaceuticals subject to sterility requirements
  • Individual practical test in the production of pharmaceuticals subject to sterility requirements, up to 2 hours

If the practical test is not approved, arrangements will be made for another attempt before the ordinary exam. Approval is required in order for the student to be able to take the ordinary exam. Students are entitled to a third attempt before the resit/rescheduled exam.  If a piece of required coursework is not approved, this may lead to delayed progress in the programme. 

Assessment

Supervised individual written exam, 4 hours

Permitted exam materials and equipment

Calculators, all types

Grading scale

Grade scale A-F

Examiners

All exams are assessed by two examiners. At least 30% of the exam papers will be assessed by an external examiner. The external examiner’s assessment should benefit all the students.

Overlapping courses

  • 10 credits overlap with the course FARMA2120 Biopharmaceutics and Pharmaceutical Science