Drug Development (DD)

Course No.:

DD

Course Title:

Drug Development

Hours Total:

150 h

Credit Points:

5 ECTS

Course Type: Pflicht

Course Availability: WS, SS

Course Duration: 1 Semester

Admission Requirements:

None

Course Coordinator / Instructor:

See current list of tutors in the Learning Management System

References to Other Modules:

Please see module description

Course Description:

The course describes the discovery and selection of compounds for human diseases and the paradigm shift from a random search to a rational approach.

The requirements of preclinical development, pharmacokinetics, and pharmacodynamics, drug interactions, and bioequivalence as well as the phases of clinical development from Phase I – IV will be discussed.

Course Objectives and Outcome:

On successful completion of this module, students will be able to:

• describe the preclinical drug development process
• analyze the selection criteria for drug candidates during drug development
• describe the pharmacology of drugs used in cardiovascular, nervous system, chronic inflammation, and oncology
• describe the basic concepts of pharmacokinetics and its consequences for drug development
• discuss what makes a “good” drug
• review the main principles governing the therapeutic use of drugs
• understand the principles of the clinical stages of drug development
• understand why and how drugs are withdrawn from the market

Teaching Methods:

This course is taught in blended format. It consists of 120 h directed, remote learning (via recorded presentations, self-readings, and exercises), followed by 4 days of full-time, face-to-face training in form of lectures, supplemented by class discussions. Class discussions refer to the concepts being introduced and case studies.

Course Content:

1 Overview and History

2 Current Trends in Drug Development

3 Target Selection and Preclinical Development

4 Rational Approach versus Serendipity

5 Guidelines for Preclinical Research

6 Scaling from Animal to Human

7 Pharmacokinetics: Physiology, Physicochemistry and Mathematical Description of Absorption, Distribution, Metabolism, and Excretion of Drugs

8 Phase I Studies: First in Human Studies, Safety and Tolerability, Drug Interaction and Bioequivalence: Aims and Study Design

9 Phase II-IV Studies: From Proof of Concept to Post Marketing Surveillance

Literature:

• Hill, R. G., & Rang, H. P. (Eds.). (2013). Drug discovery & development: Technology in transition (2nd ed.). London: Churchill Livingston Elsevier.
• Rowland, M. & Tozer, T. N. (2007). Clinical pharmacokinetics and pharmacodynamics: Concepts and applications (4th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
• DiMasi, J. A., Feldman, L., Seckler, A., Wilson, A. (2010). Trends in risks associated with new drug development: Success rates for investigational drugs. Clinical Pharmacology & Therapeutics, 87(3), 272–277.

Prerequisites to Qualify for Assessment:

• Course evaluation

Assessment:

• Research essay, 15-20 pages (DIN A4)

Student Workload (in hours): 150

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