Using quality by design (QbD) principles, an experimental plan and subsequent model were developed to systematically evaluate these factors. From the developed stability model, a strategy was determined to facilitate packaging selections, storage conditions and justification of specifications. The ability to use this model to determine the product packaging and justify the product specifications is crucial to patient safety and critical for a successful regulatory filing. Finally, discussed are the regulatory implications and how this information can be used in conjunction with ICH stability studies.
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