In its simplest terms, Dose Formulation Analysis (DFA) verifies all solutions used in preclinical toxicology studies. For FDA IND applications, dose formulation analysis is critical. Some companies are unfamiliar with the DFA process or have questions about what to expect. Below are typical questions concerning Dose Formulation Studies:
Do we have to test the dose formulation if it is a suspension as opposed to a solution?
Regardless of the type of formulations, the concentration must be verified for a study to be considered a complete IND submission. A solution or suspension depends on the drug’s solubility and dose concentration. Whether your formulation is is a suspension or solution, homogeneity testing provides essential data for your IND submission. This involves taking subsamples from the top, middle, and bottom of a dose formulation and analyzing them for concentration. Solutions will have equal concentrations in all strata; suspensions could have different concentrations across strata.
What steps are needed from an analytical standpoint to analyze my dose formulation samples?
The test method is developed to determine optimal parameters for separating and detecting the drug from all other components of the dosing formulation. The method is designed to handle all dose formulation concentrations. Once developed, the method is validated to confirm linearity, accuracy, precision, specificity, limit of quantitation, and stability. We prepare test formulations to challenge this method providing data that study samples will perform as expected. Formulation stability and diluted samples are evaluated from room temperature to frozen conditions. Once validation is complete, a comprehensive report is written, including all test method details and statistics. We are then ready for study sample arrival, and KCAS will return QC’d data within 4 business days.
How Many Methods Will Need to be Validated?
For different preclinical studies, you don’t need to validate different test methods if you are dosing the same formulation. We design a single test method to cover multiple studies for that formulation. We will validate just one method to support all of your tox studies.
KCAS has a dedicated dose formulation team ready to start your project. For study samples, we deliver QC’d data within 4 business days. Our experts have deep knowledge in preclinical testing, stability, and analyzing dose formulations. Give KCAS a call today.