Developmental, Reproductive and Juvenile Toxicology
Developmental and reproductive toxicology studies are a required component of regulatory submission packages for pharmaceuticals, food additives and chemicals. Juvenile studies are part of the pediatric assessments required for the NDA submission in North America or marketing authorization application in Europe. Ricerca scientists have unrivaled experience in designing and conducting all of the necessary investigations. Studies are performed in state-of-the-art, GLP-compliant facilities.
Ricerca's developmental, reproductive and juvenile toxicology services include:
DART studies for pharmaceuticals, according to ICH guidelines
- Embryotoxicity (teratogenicity): rats, rabbits, mice and minipigs
- Fertility: rats, mice and rabbits
- Peri- and post-natal development: rats and mice.
Developmental toxicity studies for vaccines, according to FDA CBER guidelines
- Pre- and post-natal antibody transfer studies: rats, mice and rabbits
- Developmental toxicity study: rats, mice and rabbits
DART studies for chemicals, according to EPA and OECD guidelines
- Prenatal toxicity (teratogenicity): rats, rabbits, mice
- Reproduction (multigeneration or extended single generation): rats, mice.
DART studies for food additives, according to FDA ‘redbook’ guidelines
- Prenatal toxicity (teratogenicity): rats, rabbits, mice, minipigs
- Reproduction (multigeneration): rats, mice
Pediatric investigations according to FDA and EMA guidelines
Juvenile toxicity: rat, mouse, minipig, dog, rabbit.