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Analysis of Test and Control Article Formulations
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Item Number: NWRR4181
A procedure for analyzing test and control article formulations, including analytical requirements, method validation, sampling and stability assessment, and quality of dose formulations. This procedure applies to formulations prepared for nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). This seven-page document assigns responsibility for each step of the procedure.
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