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Drug Development (DD)

Module Title: Drug Development

Module No.:

DD

Semester / Term:

--

Duration:

1 Semester

Module Type(s):

Pflicht

Regularly offered in:

WS, SS

Workload: 150 h

Credit Points: 5

Admission Requirements:

None

Language of Instruction:

Englisch

Contributing Courses to Module:

Workload:

Lectures: 30 h
Self-study: 90h
Self-testing: 30 h

Course Coordinator(s) / Tutor(s):

Module Director:

PD Dr. Matthias Grossman

References to Other Programs:

• N/A

References to Other Modules in the Program:

• Medical Writing
• Conducting Clinical Trials

Qualification and Educational Objectives of the Module:

This course is a thorough introduction to clinical research in which students learn to understand the drug development process from discovery through market approval and beyond.

Course Content of the Module:

• Overview and history
• Current trends in drug development
• Target selection and preclinical development
• Guidelines for preclinical research
• Scaling from animal to human
• Pharmacokinetics: Physiology, physicochemistry and mathematical description of absorption, distribution, metabolism, and excretion of drugs
• First in human studies, safety and tolerability, drug interaction and bioequivalence: Aims and study design
• From proof of concept to post marketing surveillance

Teaching Methods:

See the contributing course outline(s)

Literature:

See the contributing course outline(s)

Percentage of the Module Grade Relative to the Final Grade for the Program:

--

Prerequisites to Qualify for Assessment:

Assessment:

See course outline(s)

Research essay, 15-20 pages (DIN A4), 100%