Growing pressure in the market is changing drug development, requiring researchers to accelerate early phases to create late-stage pipeline growth. Intox can help you submit investigational new drug application successfully and efficiently.

These IND-enabling programs require specific studies that evaluate the efficacy and safety of the product. Pharmacology studies most often consist of in vitro and in vivo studies, the new drug’s intended target, and the desired effect. Once proof-of-concept is demonstrated in the pharmacology studies, the nonclinical safety studies (i.e., the toxicology studies) evaluate the safety profile of the drug.

This includes profiling the drug’s effect on DNA (genotoxicity), critical organ systems (i.e., cardiovascular, respiratory, and central nervous system effects through safety pharmacology), and general toxicity (through animal studies in rodent and nonrodent species). Data is then collected and delivered as a report to the client, along with the necessary SEND datasets for final submission.

IND-enabling studies:

  • Exploratory Toxicology
  • DMPK Studies
  • Mammalian Toxicology
  • Genetic Toxicology Testing
  • Analytical / Bioanalytical Capabilities
  • Safety Pharmacology Studies