Together on the trail to the summit

Non Clinical

SAFETY, STUDY AND SCIENTIFIC ASSESSMENTS

DDC has extensive experience in establishing effective strategies for conducting various in vitro and in vivo nonclinical safety assessments for a large variety of drugs and biologics in different therapeutic classes.

DDC develops an accelerated IND-enabling program specifically for each new drug candidate. The goal is the successful filing within the shortest possible time to initiate the FIH trial.

DDC’s has extensive experience in general toxicology, reproductive and developmental toxicology, male fertility assessment, pediatric studies, safety pharmacology (in vitro and in vivo), dosage form development, and safety assessments for the qualification of impurities, degradants and residual solvents.

In addition, DDC has current state-of-art expertise to conduct QSAR assessments according to the M7 ICH Guideline employing both Expert Ruled and Statistical models. Both models are required by FDA to facilitate identification of a drug candidate with the most favorable toxicology profile for human safety. This approach has been used successfully for the qualification of process impurities and degradants with regards to their genotoxicity and carcinogenicity potentials.

DDC’s DVM expert in toxicologic pathology has extensive National Toxicology Program experience. Our pathologist provides an external peer review to clarify the meaningfulness of potential adverse microscopic findings.