Regulatory background

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

Pharmacological-toxicological documentation

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

General principles of toxicity studies

• In vitro
• In vivo

Pharmacology

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

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

Juvenile Toxicity Testing 

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

Reproductive toxicology

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

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

Impurities 

• Impurities in Drug Substance/Product
• Genotoxic Impurities

Carcinogenicity

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

Specialities (2)

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

Specialities (3)

• ERA
• Anticancer drug development
• Contamination of controls

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