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 |
| 1 | Target Animal Safety Chicken |
| 2 | *Target Animal Safety Cattle, Dog & Swine |
| 3 | Genotoxicity Testing -Ames, in vitro & in vivo chromosomal aberration |
| 4 | Repeat-Dose (90-Day) Toxicity Study -Rat |
| 5 | Repeat-Dose (90-Day) Toxicity Study -Dog |
| 6 | Two Generation Reproduction Toxicity Study-Rat |
| 7 | Developmental Toxicity Testing -Rat and (Rabbit: Optional) |
| 8 | Chronic Toxicity Study Rat and (Dog: Optional) |
| 9 | Carcinogenicity Study -Rat/Mouse |
| 10 | Combined Chronic Toxicity/Carcinogenicity Study-Rat/Mouse |
| 11 | Metabolism study in Rats |
| 12 | Metabolism study in Chicken |
| 13 | *Metabolism study in Cattle or Swine |
| 14 | Residue study in Chicken |
| 15 | *Residue study in Cattle or Swine |
*Studies performed at strategic partners facility
