Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms.

With the current technologies for powder blend sampling, blend segregation during sampling (sampling bias) especially for granular blends will unavoidably occur, resulting in deviated (biased) blend assay results. This article introduces the concepts of pooled variance and the central limit theorem,...

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Publicado en:Pharmaceutical Technology Vol. 41; no. 2; pp. 42 - 50
Autor principal: Cholayudth, Pramote
Formato: Journal Article
Publicado: MJH Life Sciences Feb2017
Acceso en línea:Ver este registro en EBSCOhost
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        au: Cholayudth, Pramote
        affil: Founder and manager of PM Consult
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      ab: With the current technologies for powder blend sampling, blend segregation during sampling (sampling bias) especially for granular blends will unavoidably occur, resulting in deviated (biased) blend assay results. This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
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