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General method validation guidelines for pharmaceutical samples.

E L Inman·J K Frischmann·P J Jimenez·G D Winkel·M L Persinger·B S Rutherford
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Abstract

Method validation guidelines, which provide an organizational structure for the design and evaluation of a validation procedure, are presented for a wide range of pharmaceutical applications. The validation guidelines are based on the analyte concentration/sample matrix combination to which the method will be applied. These guidelines include the selection of appropriate validation parameters, design considerations for evaluation, and a discussion of acceptance guidelines for the determination of acceptable method performance. A set of tables is included which illustrates the selection and testing procedure and tailors the entire validation process to the specific characteristics of the determination to be made.

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Chemistry, PharmaceuticalDrug StabilityPharmaceutical PreparationsReference StandardsJournal Article

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BibTeXRIS

E L Inman, J K Frischmann, P J Jimenez, G D Winkel, M L Persinger, B S Rutherford. 1987. General method validation guidelines for pharmaceutical samples.. https://doi.org/10.1093/chromsci%2F25.6.252

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