Case Study: In Vivo Efficacy Focus

Background:

The client had a drug in clinic in an oncology program. The drug had good potency against the target and in animal models.

Problem:

• Unexpected bioanalytical results were obtained in the clinic. The parent compound disappeared rapidly in plasma.
• The metabolic pathway of the compound was unknown.
• Pharmacokinetic studies were compromised by ex vivo metabolism of the compound.

Solution:

• Apredica scientists developed analytical methods for the compound and potential metabolites.
• Metabolites in plasma samples were identified.

Results:

• An oxidation product was postulated as a potential metabolite.
• An analytical method was developed rapidly.
• In vitro results reproduced in vivo results.
• A novel metabolism pathway in plasma was identified.
• The client was provided with the information needed to make a decision on how to proceed.

Contact us to learn more about Apredica's metabolite ID services.