Developing pediatric drugs traditionally relies on extrapolating data from adult clinical trials, assuming that children have similar toxicity profiles and treatment responses. However, critical physiological differences, including ongoing organ development and distinct metabolic and pharmacodynamic profiles, can result in unique pediatric toxicities. According to FDA and EMEA guidelines, juvenile animal toxicity studies are mandatory when existing data cannot confirm a drug’s safety for pediatric trials.
At Scantox, our preclinical juvenile toxicity studies are designed to bridge this gap, ensuring drugs are safe and effective for pediatric use before advancing to human trials.
Juvenile Toxicology Study Design
Sponsors must justify their study designs, including the choice of animal species and the age at the start of dosing, based on the disease indication, administration route, and patient age. Additionally, regulatory approval is required before initiating studies.
With deep preclinical expertise, Scantox supports the design, execution, and management of preclinical juvenile programs from exploratory to GLP-compliant phases. Key considerations in our study designs include:
- Animal selection: Choosing species, age, sex, and number of animals based on study requirements, such as determining piglet numbers from expected litter sizes.
- Administration Details: Specifying route of administration, dose levels, schedules, and formulations.
- Endpoints and Sampling: Defining toxicologic endpoints and biological specimen volumes and collection methods (e.g., advanced microsampling techniques)
At Scantox, minipigs are our non-rodent model of choice due to their anatomical and physiological similarities to humans, particularly in skin, heart, and gastrointestinal tract development. Their developmental stage at birth closely resembles that of humans, making them ideal for juvenile studies.
Farrowing of Göttingen Minipigs
Our protocol includes acquiring maternal minipigs weeks before farrowing to ensure optimal preparation for birthing.
Our proximity to and partnership with Ellegard Göttingen minipigs A/S ensures rapid delivery of suitable dams. We synchronize birth dates across multiple animals to maintain consistent age groups for dosing schedules, which is crucial for successful treatment administration.
Study Outputs
Scantox meticulously tracks various metrics to ensure comprehensive coverage of potential developmental impacts:
- General Health: Regularly monitoring body weight, food consumption (post weaning), and clinical observations.
- Growth and Developmental Parameters: Measurements of crown-rump length and femur-tibia dimensions (at necropsy).
- Advanced Diagnostics: Including ophthalmology, ECG, and detailed clinical pathology.
- Neurobehavioral Assessments: Evaluating mental status, ear reflex, muscle tone, etc.
- Pharmacokinetic Assessments: Studying bioavailability and toxicokinetics.
- Morphological Evaluations: Conducting thorough macroscopic and microscopic observations, including necropsy and histopathology.
Microsampling Technique
Our advanced microsampling technique allows us to collect minimal blood volumes from minipigs, typically only 50 to 100 microliters. This method significantly reduces the amount needed for analysis, minimizing animal stress.
Sampling Sites:
- Ear Vein: Easy access with minimal discomfort.
- Hind Leg: Alternative site for diverse study requirements.
These refined techniques are advantageous in scenarios requiring minimal stress and sample volume, ensuring animal welfare and study integrity.
Why Choose Scantox?
- Global Leader in Minipig Juvenile Studies: Since 2007, Scantox has been a pioneering leader in minipig juvenile toxicology studies.
- Extensive Experience: Scantox has diverse expertise, including conducting oral bioavailability studies and pharmacokinetic profiles in lactating sows and their offspring and specializing in intravenous injection and dermal applications for juvenile minipigs.
- Flexibility: Our team is used to adapting dosing procedures for young animals and developing innovative solutions for complex scenarios. Scantox pathologists excel in detecting developmental changes and examining intricate structures like the brain.
- Commitment to Excellence and Animal Welfare: We adhere to the highest animal welfare standards, ensuring ethical practices and reliable research outcomes.
FAQs
In traditional reproductive toxicity studies the adult animals are dosed and evaluation of offsprings focus mainly on prenatal impacts with minimal postnatal evaluation. Juvenile toxicity studies, however, assess drug effects following administration to the offsprings during postnatal development, bridging the gap between animal reproductive studies and adult toxicity evaluations.