Melissa Whitsel

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.

Uniform dose formulation is key to meeting safety study requirements.

When designing stability protocols, formulation, storage, and dosing conditions must be assessed.

A number of factors need to be considered when evaluating preclinical dose-formulation stability. The authors discuss formulation, storage and dosing conditions.