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Safety Evaluation for Pediatric Medications

Pediatric drug development is both a priority and a challenge in the global pharmaceutical field. Its safety evaluation must take into account the physiological particularities of children, differences across developmental stages, and the risks associated with long-term medication. Topgenebio focuses on providing innovative pharmaceutical companies, biotech firms, and research institutions with full-cycle, highly sensitive, and customized non-clinical safety evaluation solutions, helping to accelerate the clinical translation of pediatric drugs and ensure safe and compliant medication use.

Scope of Drug Coverage

Our services span 8 core pediatric therapeutic areas: 

 

Anti-infectives (e.g., antibiotics, antivirals)
Neurological agents (e.g., epilepsy treatments, ADHD medications)
Antineoplastic & immunomodulators (e.g., targeted therapies for pediatric leukemia, immunosuppressants)
Respiratory drugs (e.g., asthma therapies, cystic fibrosis medications)
Endocrine & metabolic drugs (e.g., growth hormones)
Vaccines (e.g., novel adjuvant vaccines, combination vaccines)
Rare disease therapies (e.g., gene therapies, enzyme replacement therapies)
Nutraceuticals & TCM compound preparations (requiring safety reevaluation)

 

Evaluation Framework

 
Developmental Toxicology Studies
•Multi-Stage Research: Covers studies from the embryonic-fetal period to adolescence, simulating the sensitivity of children's organ development.
•Special Technologies: Tracking of cross-species developmental models (rodent + non-rodent), repeat-dose toxicity in pre-weaning and early post-weaning juvenile animals (rodent + non-rodent), etc.
 
Pharmacokinetics (PK) & Pharmacodynamicst
Child-specific parameters: Hepatic/renal metabolism simulation, blood-brain barrier permeability analysis, age-dependent exposure modeling.
 
Immunotoxicity Assessment
Focused evaluation of drug-induced immune system disruptions (e.g., thymic toxicity, vaccine-associated hypersensitivity).
 
Neurobehavioral & Cognitive Assessments
Quantitative analysis of motor function, learning-memory, and social behavior alterations in juvenile animals..
 
Genotoxicity & Carcinogenicity Risk Screening
Integrated in vitro micronucleus assay + in vivo transgenic models for early-stage risk identification.
 
Long-term Safety & Reproductive System Impact
Longitudinal tracking of gonadal development, pubertal onset, and fertility indices to support full drug lifecycle management.

Technical Advantages

Advanced Pediatric-Specific Experimental Capabilities
Equipped with specialized instruments and devices for semen collection, sperm analysis, ultrasound, X-ray, and maternal-infant interaction recording. These devices meet various experimental testing requirements and ensure the accuracy and reliability of data.

in Rat
PND₁:(Postnatal Day 1, i.e., the second day after birth): Intramuscular injection
PND₃:Oral gavage
PND₉:Blood collection
PND₁₀:Maternal milk collection
PND₁₅:Tail vein injection
PND₂₁:All routine procedures can be performed.
in Rabbit 
PND₂₁: Routine procedures such as intramuscular injection, blood collection, gavage, intravenous injection, and subcutaneous injection can all be performed.
in Non-Human Primates (NHPs) 
PND₃: Bone mineral density (BMD) scanning
PND₂₁: In additional to BMD scanning, Routine procedures such as intramuscular/ intravenous/ subcutaneous injection, blood collection can all be performed

Project experience

30+ pediatric drug preclinical safety evaluation programs completed
20+ approved INDs/NDAs across therapeutic categories:Gene therapy products, Traditional Chinese Medicine, Small molecule drugs

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