SU801: Drug Development (5 ECTS)

STADS: 29000701

Level
Master's level course

Teaching period
The course is offered in the spring semester.
3rd quarter.

Teacher responsible
Email: kbrosen@health.sdu.dk

Timetable
Group Type Day Time Classroom Weeks Comment
Common I Monday 09-12 Aage Berntsen 08
Common I Monday 13-16 Aage Berntsen 08
Common I Tuesday 13-16 Aage Berntsen 08
Common I Tuesday 09-12 Aage Berntsen 08
Common I Wednesday 09-12 Aage Berntsen 08
Common I Wednesday 13-16 Aage Berntsen 08
Common I Thursday 09-12 Aage Berntsen 08
Common I Thursday 13-16 Aage Berntsen 08
Common I Friday 09-12 Aage Berntsen 08
Common I Friday 13-16 Aage Berntsen 08
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Comment:
Uge 8.

Prerequisites:
None

Academic preconditions:
Passed Bachelor in Lægemiddelvidenskab eller farmaceutisk kemi.

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, patents, high throughput screening, medicinal chemistry in vitro and in vivo pharmacology, in vitro and in vivo metabolism, quality control, toxicology, animal ethics, pharmacokinetics, clinical studies, bioanalysis, drug monitoring, marketing, regulatory requirements and registration, production.

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:
(a) Written exam. Pass/fail, internal evaluation by teacher.

Reexam after 4th quarter.

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

Forelæsninger, antal timer 30.
Kurset afholdes som et ugekursus. Forelæsningerne vil blive afholdt af industriforskere med speciale indenfor de enkelte områder.
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.