Juvenile toxicology assessment is required for all pharmaceutics that are intended for potential use in children. Creative Animodel provides services that can help you to obtain critical information on the potential safety concerns of your pharmaceutical and biopharmaceutical compounds with juvenile toxicology studies. 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 interested 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:
- Juvenile toxicity studies
- Developmental toxicity studies for vaccines in rodents or rabbits
Routes of administration:
- Oral : gavage, dietary admixture, drinking water
- Dermal application
- Subcutaneous, intra-dermal, intramuscular and intraperitoneal
- Intravenous: bolus, slow injection, continuous and intermittent intravenous infusion
- Toxicokinetics, bioanalysis and clinical pathology
- Developmental immunotoxicology
- Developmental neurotoxicity (FOB, cognitive function, neuro-histomorphometry)
- Genomics using the Affymetrix platform
- Skeletal development evaluated in vivo by X-ray, DXA, pQCT and microCT
-An experienced team with state-of-the-art technology to help you assess the toxicity risk
-Personalized program design to meet your specific needs including non-standard and customized studies
-Services follow regulatory guidelines to ensure test reliability, high quality, timeliness, and cost-effectiveness
-Comprehensive supportive services
Typically toxicity studies are performed on the Sprague Dawley rat, however, our experts can also adapt the testing for 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.
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.