Читать книгу Clinical Pharmacology and Therapeutics - Группа авторов - Страница 121

In vivo studies in animals are essential to assess a drug in development for desirable pharmacological properties and potential toxic effects before being studied in humans. Acute, and in most cases chronic, toxicity studies will be carried out in animals, using increasing doses, until clear toxic effects are noted, including a proportion of the animals dying. These studies provide ‘pointers’ to focus the safety assessments in human studies. In Europe, the guidelines require that the toxic effects of the drug should be assessed in two mammalian species (one non‐rodent) over 2 weeks of dosing before a single dose is administered to humans. Mutagenicity, carcinogenicity and the impact of drugs on reproduction are assessed and pharmacokinetic studies in animals can be used to help predict doses needed when first used in humans.