WestChina-Frontier has constructed a comprehensive study system for pediatric drugs, having completed the evaluation of more than 50 pediatric drugs in juvenile animals (the experimental animal species include: neonate rats, neonate rabbits, juvenile pigs, juvenile dogs); the evaluated pediatric drugs are indicated for hand-foot-and-mouth disease, infantile eczema, pediatric myopia, precocious puberty, anti-tumor, neonatal jaundice, skin haemangioma, psoriasis, etc.

Type of studies conducted：

Single-dose studies, repeat-dose studies, TK studies, genotoxicity tests, safety pharmacology tests.

Routes of administration in juvenile rats: Oral gavage, intravenous injection, subcutaneous injection, percutaneous application, intramuscular administration, nasal drip (nasal spray), eye drop, etc.

Blood sampling methods for juvenile rats: Routine blood sampling, trace amount blood sampling.

Test indexes in juvenile rat study

Routine toxicology evaluation endpoints：

· Growth measurement；

· Examination of sexual development；

· Reversibility/persistency of toxicity in recovery period；

· Toxicokinetics；

Special evaluation endpoints：

· Female/male fertility (mating, including sperm parameters)；

· Central nervous system and/or behavioral function tests；

· Immunotoxicity parameters；

· Other endpoints established based on preliminary safety data or theoretical concerns；