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        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Studienmodule

MDRA-25 (WS 2023/2024 und SS 2024)

Modul 9 Pharmakologisch-toxikologische Dokumentation

Dokumentation der Pharmakologie, Toxikologie, Genotoxizität und Ökotoxikologie

  • Overview
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  • 6
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  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper and written examination 6
Module leader
Prof. Dr. Gerd Bode

Module contents

1) Regulatory background

  • Council regulations/AMG
  • Preclinical guidelines/ICH process
  • GLP
  • Animal welfare
  • The preclinical scientific advise procedure
  • Counterfeit Medicine

2) Pharmacological-toxicological documentation

  • Common Technical Document (CTD-S)
  • Nonclincal overview / Summaries
  • Bibliographic documentation

3) General principles of toxicity studies

  • In vitro
  • In vivo

4) Pharmacology

  • Objectives
  • Pharmacodynamic effects relating to the proposed indications
  • Safety pharmacology
  • Assessment of the Potential for QT-interval prolongation
  • Drug interaction

4a) Pharmacokinetics/Toxicokinetics/Metabolism

  • Objectives
  • Pharmacokinetics after a single dose
  • Pharmacokinetics after repeated administration
  • Distribution in normal and pregnant animals e.g. autoradiography, Biotransformation
  • Repeated Dose Tissue Distribution Studies
  • The Assessment of Systemic Exposure in Toxicity Studies/Toxicokinetics
  • Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Medicinal Products
  • In Vivo Drug Metabolism/Drug Interaction Studies

4b) Juvenile Toxicity Testing

5a) Single dose/Repeated dose toxicity

  • Objectives
  • Species selection
  • Route of administration
  • Duration, dose frequency
  • Number of animals and groups
  • Data evaluation and presentation
  • The Assessment of Systemic Exposure in Toxicity Studies/Toxicokinetics

5b) Local tolerance / Phototoxicity

5c) Inhalation toxicity

6) Reproductive toxicology

  • Objectives
  • Fertility and early embryonic development
  • Embryo-fetal development
  • Prenatal and postnatal development, including maternal function

7) Genotoxicity

  • Objectives and reasoning for genetic toxicity testing of pharmaceuticals
  • Genotoxic mechanisms, impact of metabolism, threshold mechanisms, relevance for carcinogenicity
  • Regulatory test systems
  • Assessment of test results
  • Regulatory experience with submissions

8) Impurities

  • Impurities in Drug Substance/Product
  • Genotoxic Impurities

9) Carcinogenicity

  • Need for Carcinogenicity Studies of Pharmaceuticals
  • Testing for Carcinogenicity of Pharmaceuticals
  • Dose Selection for Carcinogenicity Studies of Pharmaceuticals

10) Specialities (2)

  • Preclinical testing strategies
  • Timing of preclinical studies
  • Biotechnology derived products

11) Specialities (3)

  • ERA
  • Anticancer drug development
  • Contamination of controls

12) The preclinical section of the SPC

  • Objectives
  • Content and structural format
  • Pregnancy: From testing to labelling
  • Cross species considerations
  • Prediction of potential adverse effects in humans

Study plan

Part 1
Friday 24.05.2024 von 08:30 - 18:30 Uhr Online
Saturday 25.05.2024 von 08:00 - 16:00 Uhr Online
Part 2
Friday 07.06.2024 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V.
Saturday 08.06.2024 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V.
Submission of study paper Sunday, 26.05.2024  

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