New Animal Drug Application (NADA) Studies:
Human Food Safety and Target Animal Safety

Adgyl Lifesciences provides comprehensive solutions for target species safety and human food safety required for New Animal Drug Application (NADA) submission to get market permission. Adgyl has 30+ years experience and team of Veterinary Pharmacologists and US Board Certified Toxicologists to design your product testing to meet global regulatory requirement.

SI. No.Studies Required for Veterinary Pharmaceutical Product used in Food producing Animals
1Target Animal Safety Chicken
2*Target Animal Safety Cattle, Dog & Swine
3Genotoxicity Testing -Ames, in vitro  & in vivo chromosomal aberration
4Repeat-Dose (90-Day) Toxicity Study -Rat
5Repeat-Dose (90-Day) Toxicity Study -Dog
6Two Generation Reproduction Toxicity Study-Rat
7Developmental Toxicity Testing -Rat and (Rabbit: Optional)
8Chronic Toxicity Study Rat and (Dog: Optional)
9Carcinogenicity Study -Rat/Mouse
10Combined Chronic Toxicity/Carcinogenicity Study-Rat/Mouse
11Metabolism study in Rats
12Metabolism study in Chicken
13*Metabolism study in Cattle or Swine
14Residue study in Chicken
15*Residue study in Cattle or Swine

*Studies performed at strategic partners facility