FARM5110 – Industrial pharmacy
Course content
The course will provide the students with in-depth knowledge of research and development (R&D) from explorative phase (medicinal chemistry, pre-clinical in vitro and in vivo studies of effect and toxicity, pre-formulation) to optimization of formulation, pilot-plant and production scale-up, as well as regulatory framework. Methods to identify and develop qualitatively good drug candidates in drug discovery and development are central. Important concepts and principals in modern pharmaceutical industry, such as QbD (Quality-by-Design) and PAT (Process Analytical Technology) will be discussed.?
Learning outcome
After completing the course:
- you have advanced knowledge of modern industrial research, development and production of new drug substances and products.
- you have in-depth knowledge of relevant modern technology, principals and models for rational industrial R&D.
- you can in collaboration prepare and present suggestions to solve complex R&D challenges.
- you can communicate about professional challenges and interventions with a broad range of professions and experts (e.g. chemists, physicians, biologists, molecular biologists, regulatory affair specialists).
- you can analyze challenges within a chosen area of specialization (medicinal chemistry, pre-clinical efficacy and safety, pharmaceutical technology including regulatory pharmacy) and independently suggest evidence-based answers.
Admission to the course
The course is mainly open to students who have been admitted to the 5-year Master`s Programme in Pharmacy at the Department?of Pharmacy, University of Oslo. In the event that space is available, other master`s level students may apply. Knowledge in relevant subject area corresponding to the content of Semester 1 through 7 at the Department’s Master`s Programme in Pharmacy is required. For more information, please contact the Study Administration at the Department of Pharmacy, studieinfo@farmasi.uio.no.
Formal prerequisite knowledge
Passed the exam in:
- FARM1100 – Pharmaceutical Chemistry
- FARM1110 – Pharmacology, Physiology and Cell Biology 1
- FARM1120 – Social Pharmacy
- FARM1130 – Pharmaceutically Based Organic Chemistry
- FARM1140 – Pharmacology, Physiology and Cell Biology 2
- FARM1150 – Pharmaceutical Based Biochemistry
- FARM2100 – Medicinal Chemistry
- FARM2110 – Pharmacotherapy 1
- FARM2120 – Pharmaceutics and Biopharmaceutics
- FARM2130 – Pharmaceutical Analytical Chemistry
- FARM2140 – Pharmaceutical Microbiology
- FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production
- FARM3100 – Pharmacognosy
- FARM3110 – Pharmacotherapy 2
- FARM3120 – Medicine Use and Public Health
- FARM3130 – Advanced Pharmacy Practice Experience (APPE)
- the compulsory HSE-courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety required for students at the 5-year Master`s Programme in Pharmacy.
Approved the compulsory parts of:
- FARM4100 – Personalised Drug Therapy
- FARM4110 – Comprehensive Biopharmacy and Formulation Technology
- FARM4120 – Drug Development
Formal prerequisite knowledge for students admitted to Studiel?p for farmas?yter med mastergrad fra land utenfor EU/E?S:
- FARM4910K – Farmakoterapi og samfunnsfarmasi med fokus p? norske terapitradisjoner og norske forhold
- FARM4920K – Fra virkestoff til ferdig formulering med fokus p? avanserte legemiddelformer
- FARM4930K – Kvalitetssikring ved produksjon og klinisk utpr?vning av legemidler
- approved the compulsory HMS-courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety required for students at the 5-year Master`s Programme in Pharmacy.
Teaching
Lectures and student active teaching such as seminars,?group/project work and flipped teaching. In addition, excursion(s) to industrial pharmacy sites. Specialization in one of three areas will be offered: medicinal chemistry, pre-clinical in vitro and in vivo studies and pharmaceutical technology including regulatory pharmacy.
The industry seminar is compulsory.
Participation in teaching related to specialization area and group work is compulsory.
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Joint teaching: 20 hours
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Student active teaching: 12?hours
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Project work i groups with oral presentation
Compulsory participation in the course must be completed and compulsory submissions must be approved to pass the exam.
Read about what applies in the event of absence from compulsory activities.
As?the?teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Compulsory participation and approved assignments are valid for 3 years.
The course may be cancelled if the number of enrolled students are low.
Examination
Final oral exam which counts 100?% towards the finale grade.
Exam begins with a joint presentation of group work and continues with individual examination that also includes the specialization area.
This course has compulsory exercises that must be approved before you can sit the finale exam.
Examination support material
Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.
Language of examination
The examination text is given in Norwegian. You may submit your response in Norwegian, Swedish or Danish. English on request.
Grading scale
Grades are awarded on a scale from A to F, where A is the best grade and F?is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.