Is Preclinical Dose Formulation Stability Analysis Important?

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Is Preclinical Dose Formulation Stability Analysis Important?

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.

Want to explore more about dose formulation stability analysis? Take a closer look by reading our full article.


1 FDA, 21 CFR Part 58 Good Laboratory Practice Regulations Final Rule (Rockville, MD, 1987).
2 Whitmire M, Bryan P, Henry T, Holbrook J, et al., NonClinical Dose Formulation Analysis Method Validation and Sample Analysis. The AAPS Journal, 2010.
3 International Conference on Harmonization. ICH Q1A (R2): Stability Testing of New Drug Substances and Products (2003).
4 International Conference on Harmonization: ICH Q2 (R1): Validation of Analytical Procedures: Text and Methodology (1996).
By | 2017-07-04T10:26:53+00:00 December 1st, 2015|Blog, Homepage Featured|Comments Off on Is Preclinical Dose Formulation Stability Analysis Important?

About the Author:

MPI Research, with global headquarters in Mattawan, Mich., provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. The company offers comprehensive imaging solutions including preclinical imaging, radiochemistry, and data analysis. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.