Prior to beginning a formulation validation project, the following information will need to be provided:
- Vehicle composition and preparation
- Dose range to be validated
- Correction factor to be used at the toxicology facility
- Salt form and structure of the test article
- Any unusual steps planned for the preparation of the formulation (i.e. mixing overnight, dropwise additions, etc.)
- Planned storage conditions
If any of these changes from one study to the next, additional validation work may be required for subsequent studies. Therefore, we recommend that the initial validation parameters are broad enough to account for likely alterations.