Juvenile Toxicity studies / Pediatric indications

The number of clinical trials targeted towards pediatric patient populations is rapidly growing and so is the need for non clinical safety data supporting these initiatives. NOTOX has finalized a 15-week repeated dose study using juvenile Beagle dogs beginning from 6 weeks of age through adulthood. This specific study adds a specific focus on neurobehavioral tests in juvenile Beagle dogs to the standard battery of investigation. Using acepromazine and d-amphetamine as positive controls, neurobehavioral testing (e.g. home cage, open field and functional observations was validated in close collaboration with our colleagues at WIL Research Laboratories.

Toxicology studies in juvenile animals to support the development of pharmaceuticals for pediatric patients are aimed to obtain information on potential safety concerns that cannot be adequately addressed in human adults or in regular preclinical studies. These cases focus especially on effects on growth and development and on immature systems such as the nervous, pulmonary, skeletal, renal, reproductive, and immune systems. We can also examine potential differences in the safety profile between pediatrics and adults with metabolic, pharmacokinetic and pharmacodynamic assessments.

The necessity and design of these studies depends highly on the safety information previously generated in adults and from general non-clinical studies. This information is generally available if the pharmaceutical was originally developed for adults and treatment is planned to be extended to treatment of pediatric patients. Toxicity studies in juvenile animals are warranted when this information indicates a cause for concern in pediatrics or when the safety profile in pediatrics cannot be predicted well enough with this information.

NOTOX has adopted the development of pharmaceuticals for pediatric indications and offers these juvenile studies in both rodents and non-rodents. Our study designs are tailor-made and will depend on the specific target populations (age, gender), indications, duration of treatment, route of administration and concern for specific target organs.
Our non-clinical programs will be in line with the EMEA “guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications” and the recently updated (R2) ICH M3 guideline. In general, when development for pediatric patients is an extension from use in adults, results from a juvenile toxicity study in one appropriate species is sufficient to support a pediatric clinical trial. In case pediatric patients are the primary patient population, a more extensive preclinical program will be necessary.  We are more than happy to discuss options for designing studies to meet our clients' specific needs and concerns.

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Validation study in juvenile and adult rats

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