An update of juvenile animal studies in the European Union: What do the numbers say?
Concern has been raised about the number of juvenile animal studies (JAS) being conducted in the European Union (EU) and the number of species required. The question of whether there has been an increase in the number of JAS requested by European Medicines Agency (EMA) and the question of single or multiple species studies are the focus of this manuscript. All source data on Pediatric Investigation Plans (PIP) were obtained from EMA pediatrics website and evaluated by year as obtained and adjusted to the date of the original PIP agreement rather than the newly assigned date of the PIP modification. The analysis of the data originally suggested an increase in the number of juvenile animal studies per year post 2010. However, a thorough examination of the adjusted PIP data from the EMA from December 2007 through 2013 support that the number of JAS being included in PIPs per year is not increasing but is in fact fairly stable at 15-30% per year. The data also, as expected, support that the JAS are mostly proposed with a single species and that species is predominately the rat and that multi-species JAS for an agreed PIP are infrequent.
Drug Safety Research & Development, Pfizer Inc., Groton, CT, USA. Electronic address: mark.e.hurtt@pfizer.com.
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Drug Safety Research & Development, Pfizer Inc., Groton, CT, USA.
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D000367:Age Factors; D000818:Animals; D005062:European Union; D006801:Humans; D023421:Models, Animal; D015397:Program Evaluation; D051381:Rats; D018570:Risk Assessment; D013045:Species Specificity; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods* / Q000639:trends*
Juvenile; Juvenile Animal Studies; PIP; Pediatric