title: The evolution of juvenile animal testing for small and large molecules.
abstract: Recent formalised regulatory requirements for ensuring safe use of new drugs in children has increased the requirement, when considered relevant, to perform juvenile animal testing before commencing paediatric clinical trials. A key goal of this work is to identify or examine for a developmental or toxicity finding not seen in other toxicology testing. With our current knowledge, this paper examines what types of testing are occurring, what novel findings are being seen and their relevance in the safety evaluation process. Furthermore, trends for now and the future in the type of juvenile animal testing will be described including a need for more focused study designs and more published data on modern cross-species postnatal development.
authors.affiliation: Nonclinical Regulatory Strategy, Covance Laboratories Ltd., Otley Road, Harrogate, HG3 1PY North Yorkshire, United Kingdom. Electronic address: paul.baldrick@covance.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Baldrick
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D023421:Models, Animal; D012107:Research Design; D018675:Toxicity Tests
keywords: Juvenile animal testing; PIP; Paediatric clinical trials; Paediatric investigation plan; Regulatory agencies