Case-Study-Enabling-Formulation-Development-for-Toxicology-Studies-for-a-New-Chemical-Entity

Case Study - Enabling Formulation Development for Toxicology Studies for a New Chemical Entity

About Our Client:

Our client, US-based biotech company involved in the discovery and development of small molecule therapeutics for the treatment of cardiovascular disease.

The Challenges:

The molecule has good solid-state properties but low solubility
The molecule is neutral in nature and does not have any detectable solubility across the pH range expected in the GIT
The molecule has less than 10% bioavailability (BA) in preclinical species

To enable toxicity studies, the molecule required formulation development that could support a high dose delivery while providing a linear dose exposure in preclinical studies

Download this case study to learn how Aragen integrated pharmaceutics plus pharmacokinetics approach avoids potential delays and helps achieve substantial savings in time and development costs.

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