Studiengang „Master of Drug Regulatory Affairs"

Studienmodule

Modul 09 (WS 2016 / SS 2017)

Pharmakologisch-toxikologische Dokumentation

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

Modulleiter/in

  • Dr. Gerd Bode, Göttingen

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
 

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

5c

 

Local tolerance / Phototoxicity

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   19. Mai 2017 von 8.30 – 18.30 Uhr
Samstag   20. Mai 2017 von 8.00 – 16.00 Uhr
Ort:   Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn
Hörsaal Erdgeschoss
Teil 2:    
Freitag   02. Juni 2017 von 8.30 – 18.30 Uhr
Samstag   03. Juni 2017 von 8.00 – 16.00 Uhr
Ort:   Uni-Club
     
    Abgabe Studienarbeit: 03.07.2017

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