45-1 Ramsey Road, Shirley, NY 11967, USA 1-631-614-7828 1-631-372-1052

Toxicology

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Juvenile Toxicology

Juvenile toxicology assessment is required for all pharmaceutics that is intended for potential use in children. The studies are complicated both conceptually and logistically which should take the development of the organ systems of the child into consideration. In support of a clinical trial in the pediatric population, a juvenile animal toxicity study is likely required. Development in young animals is a continuous process with different organs maturing at different rates and time. Structural and functional maturational differences have been shown to affect drug safety. Creative Animodel offers a wide range of in vivo toxicology assays including juvenile toxicology studies for you to obtain critical information on the potential safety concerns of your pharmaceutical and biopharmaceutical compounds.

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Juvenile Toxicology Services at Creative Animodel

We have extensive knowledge and expertise in this area, our experienced team will design, perform, interpret and report your juvenile toxicity studies that will meet your specific objectives. The testing strategies/packages are designed based on the physical and chemical properties, the compound-type and targeted development stage(s) of your interesting compounds. In addition, we are familiar with international guidelines and can ensure the studies are designed according to the regulations of the international agencies.

Our studies include but are not limited to:Juvenile toxicity studies design——general toxicityDevelopmental toxicity studies for vaccines in rodents or rabbitsJuvenile toxicology studies in non-human primates

Typically toxicity studies are performed on the Sprague Dawley rats, however, our experts can also adapt the testing on mice, dogs, minipigs, rabbits, or cynomolgus monkeys. Different dose levels are selected according to the regulatory requirements. Other factors such as the proposed pediatric indication, the age of the intended population, the extent and timing of drug exposure, the likely target organ(s) for toxicity are also considered during the study design.

Routes of administration:Oral: gavage, dietary admixture, drinking waterDermal applicationSubcutaneous, intra-dermal, intramuscular and intraperitonealIntravenous: bolus, slow injection, continuous and intermittent intravenous infusion

Support services:Toxicokinetics, bioanalysis and clinical pathologyDevelopmental immunotoxicologyDevelopmental neurotoxicity (functional observational battery, cognitive function, neuro-histomorphometry)Genomics using the Affymetrix platformSkeletal development evaluated in vivo by X-ray, DXA, pQCT and microCT

Our Advantages
An experienced team with state-of-the-art technologies to help you assess the toxicity riskPersonalized program design to meet your specific needs including non-standard and customized studiesServices follow regulatory guidelines to ensure test reliability, high quality, timeliness, and cost-effectivenessComprehensive supportive services

At Creative Animodel, we have well-trained and experienced experts as well as the delicate techniques that can meet the specific requirements of our clients. We can provide a fast, reliable and cost effective service to help you to evaluate the effects of your substance on the growth and development of pulmonary, immature nervous, renal, skeletal, immune and reproductive systems. If you are looking for companies that can help you with the juvenile toxicity, Creative Animodel could be your best choice, we will partner with you to design the most appropriate, cost-effective and socially responsible protocols to get the safety assurance you need. Please feel free to contact us anytime you want.

Reference:
1. Kim, N.N.; et al. Points to consider in designing and conducting juvenile toxicology studies. International Journal of Toxicology, 2017, 36(4): 325-339.

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45-1 Ramsey Road, Shirley, NY 11967, USA 1-631-614-7828 1-631-372-1052 Europe 44-207-097-1828

Creative Animodel

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