1) Regulatory background
- Council regulations/AMG
- Preclinical guidelines/ICH process
- GLP
- Animal welfare
- The preclinical scientific advise procedure
- Counterfeit Medicine
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2) Pharmacological-toxicological documentation
- Common Technical Document (CTD-S)
- Nonclincal overview / Summaries
- Bibliographic documentation
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| 3) General principles of toxicity studies
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4) Pharmacology
- Objectives
- Pharmacodynamic effects relating to the proposed indications
- Safety pharmacology
- Assessment of the Potential for QT-interval prolongation
- Drug interaction
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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
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4b) Juvenile Toxicity Testing
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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
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5b) Local tolerance / Phototoxicity
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5c) Inhalation toxicity
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6) Reproductive toxicology
- Objectives
- Fertility and early embryonic development
- Embryo-fetal development
- Prenatal and postnatal development, including maternal function
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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
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8) Impurities
- Impurities in Drug Substance/Product
- Genotoxic Impurities
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9) Carcinogenicity
- Need for Carcinogenicity Studies of Pharmaceuticals
- Testing for Carcinogenicity of Pharmaceuticals
- Dose Selection for Carcinogenicity Studies of Pharmaceuticals
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10) Specialities (2)
- Preclinical testing strategies
- Timing of preclinical studies
- Biotechnology derived products
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11) Specialities (3)
- ERA
- Anticancer drug development
- Contamination of controls
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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
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