Preclinical Development
"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."
Toxicology and Toxicokinetics
Toxicology encompasses nonclinical safety assessment of a molecule in animals prior to entry into man. Toxicokinetics (TK) is the analysis of compound exposure data collected during nonclinical safety / toxicology studies conducted in animals. The goal of toxicology studies and assessment of toxicokinetics is to correlate findings of toxicity with a corresponding level of compound exposure.
Including TK blood sampling in toxicology studies is vital as it helps confirm systemic exposure of the compound as well as establish exposure parameters of the NOAEL (No Observed Adverse Effect Level). Attaining a robust NOAEL is a critical piece of data necessary for conducting early clinical trials in humans, in addition to in vitro activity assessment and in vivo efficacy assessment in pharmacology studies. In addition, we are able to identify potential gender differences, dose-limiting absorption and/or metabolism. This information may confirm suitability of the animal species used in the toxicity evaluations (relevance to humans), potential gender differences in humans, dose selection (maximum feasible dose), accumulation, and/or induction/inhibition of metabolism (specific to small molecules).
We have experience with studies with all routes of administration, type of toxicity study, and expertise in complex nonclinical study designs.
Our Toxicokinetics (TK) Services:
- Non-GLP TK analyses
- Study design including dose selection, frequency and sample collections for no-GLP and GLP studies
- Nonclinical protocol development
Preclinical Research and Pharmacology
Research and preclinical pharmacology are crucial in development and assessment of assets/compounds before further development of the molecule. We have extensive experience in designing and translating preclinical efficacy studies and utilizing the same in getting to first and efficacious doses in humans. We believe that utilizing preclinical models aids in better human drug development.
Preclinical Research and Pharmacology Services:
- Design of efficacy studies in mice, including syngeneic models and variety of different molecular formats
- Design preclinical pharmacology and research studies needed for IND submission and translation to human expectations
