Non-clinical Studies Directed towards NDA Filing

Adgyl Lifesciences offer comprehensive range of toxicology studies directed at NDA filing that are cost effective as well.

90-Day repeat dose toxicology studies with toxicokinetics in mice/rats
90-Day repeat dose toxicology studies with toxicokinetics in non-rodents (Beagle dog/Minipigs/NHP*)
6 to 12 Month repeat dose toxicology studies with toxicokinetics in mice/rats
9-Month repeat dose toxicology studies with toxicokinetics in non-rodents (Beagle dog/Minipigs/NHP*)
6-Month carcinogenicity study in Transgenic rasH2 mice with toxicokinetics
Fertility and early embryonic development to implantation (SEG-I) studies in mice /rats
Embryo fetal development toxicity (SEG-II) studies in mice/rats/rabbits
Pre-natal and post-natal (SEG-III) studies in rats
Juvenile toxicology studies in rats
Carcinogenicity studies in mice/rats

* NHP In-life studies will be done in partner lab and all rest of evaluations done at Adgyl.