SU801: Drug Development (5 ECTS)

STADS: 29000701

Level
Master's level course

Teaching period
The course is offered in the spring semester.

Teacher responsible
Email: kbrosen@health.sdu.dk

Timetable
Show entire timetable
Show personal time table for this course.

Prerequisites:
None

Academic preconditions:
Bachelor's degree in Pharmaceutical Sciences, Chemistry or Pharmaceutical Chemistry.

Course introduction
The aim of the course is to supply the student with in-depth knowledge about the various phases involved in the development of a new drug.

Expected learning outcome
By the end of the course the student is expected to be able to describe the various phases and disciplines involved in the development of a new drug, primarily within discovery, preclinical development, clinical development and registration. The student is expected to be able to sub-divide the clinical development into the phases 1-4 as well as shortly describe the content in and the difference between the respective phases.

Subject overview
Initiation of a project, medicinal chemistry, patents, in vitro and in vivo pharmacology, in vitro and in vivo metabolism, bioanalysis, toxicology, animal ethics, pharmacokinetics, chemical and pharmaceutical evolution, quality control, pharmaceutical chemical documantation, clinical evolution, Good Clinical Practice (GCP), regulatory requirements and registration, market access and marketing.

Literature

• Ingen litteratur, idet underviserne udleverer handouts af deres præsentationsmateriale. : .

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:
Written exam. Pass/fail, internal evaluation by teacher. The exam will take place on the last day of teaching.

Reexamination in the same exam period or immediately thereafter. The mode of reexamination may differ from the mode of exam at the ordinary exam.

Expected working hours
The teaching method is based on three phase model.
Intro phase: 42 hours

Educational activities

Language
This course is taught in Danish.

Remarks
Course material and hand-outs will be in English.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.