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| home > epc > summer 2003 > preclinical juvenile toxicity studies: will it be safe for children? |
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European Pharmaceutical Contractor
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The last issue of EPC highlighted the growth in paediatric clinical trials and difficulties in performing studies in children. Similar gaps in study cover have become an issue in preclinical studies and it is only in recent years that any studies have focused on the potential effects of direct treatment of young animals and on possible long-term effects.
The traditional pattern of preclinical research has been to investigate potential toxicity in several species of animals through a series of studies until the intended pattern of treatment in man has been covered by an appropriate treatment period in the animals. These studies monitor the effects of treatment on all the basic organ systems, haematology, clinical chemistry and organ pathology.
The preclinical package for new medicines also includes tests assessing effects on fertility, embryonic and foetal development, and postnatal development through to the second generation. In all of these reproductive test programmes the test material is administered to adult animals and the only treatment received by the offspring is via the placenta in utero, or through the milk. Previously no test was specifically aimed at examining the effects of direct administration of drugs to the offspring.
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