Formulations for glp studies

When developing a new therapy, challenges often arise during the early stages of development: outcome of preclinical assessments, timing of the project, funding, and patient needs. The path to first-in-human needs to be as fast and efficient as possible, but improper candidate selection, poor formulations, and gaps in clinical dose strategy can lead to inadequate preclinical and clinical data; often extending timelines and increasing cost.

With a handle on formulation, testing your drug for toxicity is a critical next step. Avoid getting tripped up by suboptimal formulations that don’t provide proper exposure, leading to potential costly delays. UAB uses rigorous preformulation data and guidance and allows you to test with confidence due to our ability to develop intravenous and either conventional or bioavailability enhanced oral formulations for cGLP studies that can provide maximum exposure of your molecule during toxicity studies.