| Popis: |
UNSTRUCTURED Abstract -Objectives This review represents a critical and constructive analysis of literature in the content of toxicology testing of new medicines for children. The review is generated through summary, classification, analysis and comparison of already existing material and researches on field. -Materials and methods Databases as Scopus, PubMed, Medline and Web of Science were used to extract data for the review. Search terms like “juvenile toxicity studies”, “children toxicology”, “testing of new drugs” were used. Out of 150 research articles screened, 25 most relevant studies are included in this review. -Results Whether juvenile animal toxicology studies are truly useful or necessary to support pediatric drug development is still doubtful. The current knowledge on cross-species functional and kinetic differences is not reliable, meaning that extrapolation of any toxicology study finding to an immature human may not be relevant, especially if performed at the wrong time and in the wrong species. -Conclusion Even though, great improvements and regulatory initiatives regarding juvenile toxicity studies have been accomplished, unfortunately testing new drugs in children still remains on its initial stage and lags behind to other scientific developments. In order to narrow down the juvenile toxicity studies loophole, we need to improve compliance by drug companies and research sponsors with pediatric trial obligations. |
