FARM4120 – Drug development and clinical trials

After completing the course can you:

• Describe the process necessary for the discovery, identification, development, and patenting of new drug substances.
• Explain the optimization of potential new molecular entities and describe simple molecular modeling in drug development.
• Explain the requirements for the preclinical development of drugs.
• Explain the documentation required for the pharmaceutical/chemical/biological quality of a drug.
• Explain the different phases of clinical drug trials and describe how they are planned and conducted in accordance with Good Clinical Practice (GCP).
• Describe relevant legislation and current regulations regarding the approval and monitoring of drugs/products in Norway and Europe.
• In collaboration with others, prepare a protocol for a clinical drug trial and communicate the requirements for the quality, safety, and medical efficacy of drugs to colleagues.

• 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 and Physiology 3
• FARM3120 – Medicine Use and Public Health
• completed and approved pharmacy practice period in FARM3130 – Advanced Pharmacy Practice Experience (APPE)
• passed 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.

Course exemption: Laws and regulations describing the overall learning outcome regulate the Pharmacy Programme. Exemptions are only granted if all learning outcomes in the course are covered.

Lectures and student active teaching, including a project assignment and presentation (compulsory), attendance and participation in Innovation Day (compulsory), colloquiums and seminars.

• 32 hours of lectures - the introductory lecture is compulsory
• 46 hours of student active teaching, including colloquiums, seminars, Innovation Day and project assignment

Compulsory participation in the course must be completed and approved and compulsory submissions must be approved to sit the exam. Read more about what applies in the event of absence from compulsory activities (only in Norwegian).

Access to teaching: 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.

Final written exam, 3 hours, which counts 100 % towards the final grade.

For admission to the exam the following must be approved:

• Project assignment and presentation of this
• Attendance and participation in Innovation Day

This course offers both postponed and resit of examination. Read more:

• Illness at exams / postponed exams
• Withdrawal during an examination / Resitting an examination