EPN-V2

FARB1400 Pharmaceutics and Drug Calculations Course description

Course name in Norwegian
Legemiddelfremstilling og legemiddelregning
Weight
10.0 ECTS
Year of study
2022/2023
Course history
Curriculum
SPRING 2023
Schedule
  • Introduction

    This course covers the formulation and production of non-sterile pharmaceuticals, and drug calculations. Important topics include pharmaceutical development, the study of types of pharmaceuticals and their composition, and production with pertaining quality control systems at different levels of production. The course provides a detailed introduction to practical production of non-sterile pharmaceuticals on a small scale, in which quality assurance in the production of pharmaceuticals is central.

  • Required preliminary courses

    The student must have been admitted to the study programme.

  • 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 explain the composition and production of mixtures, ointments, creams, gels, capsules, granulates and tablets in accordance with basic principles, and their stability and durability
    • can explain the physical properties of colloids and disperse systems
    • can explain physical and/or chemical factors that can influence solubility, rates of dissolubility and sedimentation
    • can explain requirements related to quality, quality assurance and control of pharmaceuticals and relevant medical equipment
    • can describe which physical-chemical properties of active ingredients and additives in a formulation are important in the preclinical work of the pharmaceutics process

    Skills;

    The student ;

    • masters relevant techniques for the production of non-sterile pharmaceuticals
    • can use relevant pharmaceutical reference works and apply academic knowledge to suggest solutions to theoretical and practical challenges related to the production of non-sterile pharmaceuticals
    • can independently create production regulations, plan, control, implement and document the production of selected pharmaceutical specimens in accordance with the relevant guidelines
    • can carry out correct drug calculations and can assess and control his/her own and other people’s calculations
    • can apply quality assurance systems and assess and handle unwanted incidents during production and the measures that must be implemented to reduce the risk of repeat incidents

    General competence;;

    The student;

    • has insight into and an understanding of the role and responsibility of pharmacists in connection with the production of pharmaceuticals
    • can discuss challenges related to pharmaceutical formulation and production without being subject to sterility requirements
    • can assess possibilities for individual adaptation of pharmaceutical formulation to create the best possible health at the individual level
    • has insight into and an understanding of how quality systems in pharmaceutics and quality and preparatory work contribute to increasing patient safety
  • Content

    Work and teaching methods include lectures, seminars, group work and group sessions.

    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.

    The lecturers will propose various topics for the thesis, and the students choose a topic based on their field of interest. The bachelor’s thesis is written in groups of between three and six students and is carried out as supervised group work. The supervisor must approve the project plan. Students are offered up to 12 supervisory sessions per thesis. If the thesis includes laboratory work, more supervision is given to ensure that the activity in the lab is conducted safely.

  • Teaching and learning methods

    Work and teaching methods include lectures, seminars, study groups, project assignments, group work and skills training in the form of laboratory assignments.

    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.

    The laboratory assignments elucidate physical-chemical principles and provide practical training in the pharmaceutics. A practical mock exam will be held at which the students are given individual feedback.

  • Course requirements

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

    • Minimum of 80% attendance at seminars
    • Minimum of 90% attendance at laboratory courses
  • Assessment

    Combined exam:

    1) Supervised individual written exam in drug calculations, 3 hours

    2) Supervised individual written exam in pharmaceutics, 4 hours

    3) Individual practical exam in pharmaceutics, 3 hours;

    A faultless exam paper is required to pass the exam in drug calculations. If a student fails the drug calculations exam, he/she must retake this part. One overall grade is awarded based on the following weighting of parts 2 and 3 of the exam: Written exam in pharmaceutics 60%, practical exam in pharmaceutics 40%. Students must be awarded a pass grade (A-E) for both parts of the exam in pharmaceutics in order to pass the course. If the student is awarded an F in one part of the exam, this part of the exam must be retaken.

    Students can appeal the grade awarded for part 1 and 2 of the exam.

  • Permitted exam materials and equipment

    The students will specialise in a research project based on a chosen research question from the field of pharmacy. The students will gain practical experience of research and develop their skills in using a chosen research method. Work on the bachelor’s thesis is centred on the selected research question and analysis and discussion of the student’s own research results, but it must also include an assessment of the student’s results in relation to publications in the relevant field.

  • Grading scale

    The student must have passed all the courses from the first year of study and may lack a maximum of one passed course from the second year.

  • Examiners

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

    Knowledge

    The student

    • has knowledge of research work in a selected area in the field of pharmacy
    • can describe key scientific methods and different research designs
    • is familiar with the strengths and weaknesses of the research method applied in his/her own project
    • can explain research ethics aspects of his/her own project

    Skills

    The student

    • can apply research-based knowledge to plan and carry out a methodical and academic project in cooperation with others
    • can obtain relevant subject matter and integrate it with his/her own knowledge of the field in his/her project work
    • can describe, analyse and discuss the research question and results of the project in relation to other published scientific work
    • can carry out independent source searches and use references and source references in a consistent and correct manner
    • can discuss, assess and argue for his/her own opinions by taking on the role of both opponent and respondent

    General competence

    The student

    • can combine academic knowledge and relevant results from research and development work in a written thesis
    • can reflect orally and in writing on academic and scientific issues
  • Overlapping courses

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

    • Minimum attendance of 80% at concluding seminars with oral presentations