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395-0204-00L 2 Credits NDS , WBZ D-HEST
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Development Process: Preclinical

Lecturers & Examiners: Dr. Alexander Krieg, Dr. Lisa Fischer
VVZ CR n/a

Last Updated: 2026-02-05 16:14:38

Abstract

An overview of the preclinical development of drugs as well as medical devices and in vitro diagnostics is given. The relevant regulations are conveyed in a practice-oriented manner.

Objective

- Understanding the principles and limitations of the preclinical efficacy and safety disciplines in product development - pharmacodynamics, pharmacokinetics and toxicology - Understanding and apply regulations for drug development, development of medical devices and in vitro diagnostics - Understanding for which purposes GLP (Good Laboratory Practice) is applied - Understanding and apply the do's and dont's of animal experiments in product development - Understanding the different possibilities and the importance of communication with the regulatory authority in early product development

Content

The Module 4 "Development Process: Preclinical" includes an overview of preclinical efficacy and safety in drug development as well as in the development of medical devices and in vitro diagnostics. Emphasis will be placed on the applicable regulations and potential interactions with regulatory authorities in early product development. When a preclinical development plan becomes necessary and what is needed to start with will be explained in a practical way. An overview is also given of which preclinical studies and documents are required in order to be able to conduct an early clinical study in humans for the first time.

General Information

Language
English
Levels
NDS , WBZ
Frequency
Yearly recurring

Examination

Type
ungraded semester performance

Registration & Places

Priority: Registration for the course unit is only possible for the primary target group

Course Components

Type Title Time & Place Hours
lecture with exercise Development Process: Preclinical
Time for the online dates: 19.01.24 (9:00- 17:00) / 26.01.24 (9:00 – 16:30) / 02.02.24 (10:00- 15:30)
  • 12.01 Date 09:15-17:00 (HG F 33.5)
  • 19.01 Date 09:00-17:00 (ON LI NE)
  • 26.01 Date 09:00-17:00 (ON LI NE)
  • 02.02 Date 10:00-16:00 (ON LI NE)
  • 09.02 Date 10:15-17:00 (HG F 26.5)
51 h semesterly

Offered In