Chapter 7 - Juvenile animal studies

Abstract

Before drugs are administered for the first time in humans, they must undergo extensive toxicology testing in test tubes and in living animals to establish safe doses and to avoid later catastrophes. But toxicities in animals are not good in predicting toxicities in humans. The most compelling reason for animal testing within the toxicology assessment of new drugs is that “something” is done, specifically, since in the past there were no good alternatives. Animal testing is increasingly challenged in the scientific discussion, as its predictive value of future adverse effects is by and large as good as tossing a coin. Many new compounds are abandoned during drug development due to toxicities in animals that do not predict toxicities in humans. Compounds declared “safe” proved nevertheless to be toxic when they were administered for the first time in humans. With “pediatric drug development,” additional juvenile animal studies (JAS) have been introduced for new drugs that, once approved, will also be used in young patients. The justifications for JAS use uncritically the administrative definition of “children” by an age limit that does not correspond to a physiological change. While all specialists agree that JAS have become an integrated part of modern drug development, with the exception of fervent supporters of “pediatric drug development,” most specialists also admit that their medical value has not been established. An analysis of modern anticancer compounds showed that the performed JAS did not add anything that could not have been deduced from the human studies. Although the costs of JAS are less than those of clinical “pediatric” studies, a critical discussion of “pediatric drug development” should include the discussion of questionable JAS.