by Roger Hayes, PhD, Senior Vice President and General Manager of Laboratory Sciences
The answer is yes! Establishing adequate stability of a preclinical dose formulation is a critical component in drug development, as it ensures that the test system receives the appropriate amount of test article based on protocol specifications. Considerations for designing adequate stability protocols must include assessment of formulation, storage, and dosing conditions.
Dose Formulation Stability Analysis
Determination of dose formulation stability is required for all preclinical regulated studies used to assess the safety of drugs. Stability assessments are completed by the analytical testing laboratory; however, these assessments cannot be completed in isolation of the test system because formulation, storage, and dosing conditions must all be considered to adequately support data collected for preclinical studies.
Analytical methods for assessing concentrations of preclinical dose formulation analysis are typically less rigorous and are validated using less stringent criteria than those for drug substance or drug products. Methods for preclinical dose formulations are developed for assay potency at concentrations appropriate for dosing in vivo studies. Moreover, the scope of validation used to support these methods is dependent upon the phase of preclinical drug development. Traditional impurity and related substance assays, which focused on quantitative analysis of impurity and degradant products, are not typically used because of long analysis run times and the resources that would be required to develop and validate these types of methods. Forced degradation studies, which are used in the development of standard impurity and related substance assays, are not required for preclinical dose formulation methods.
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