Masterstudiengang „Drug Regulatory Affairs"

Studienmodule

Modul 09 (WS 2019/ SS 2020)

Pharmakologisch-toxikologische Dokumentation

Präsenzzeit Studienarbeiten Prüfungsform Leistungspunkte
ca. 30 Stunden ca. 30 Stunden Studienarbeit und mündliche Prüfung 6

Modulleiter/in

  • Dr. Gerd Bode

Themen

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

Studienplan

Teil 1:

   
Freitag   29. Mai 2020 von 8.30 – 18.30 Uhr
Samstag   30. Mai 2020 von 8.00 – 16.00 Uhr
Ort:   Wissenschaftszentrum Bonn, Ahrstr. 45, 53175 Bonn

Teil 2:

   
Freitag   05. Juni 2020 von 8.30 – 18.30 Uhr
Samstag   06. Juni 2020 von 8.00 – 16.00 Uhr
Ort:   Uni-Club
     
    Abgabe Studienarbeit: 06.07.2020

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