Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release.

The underlying concept for acceptance value (AV) in <905> Uniformity of Dosage Units (UDU) is based on that of tolerance interval (TI). Its maximum allowed acceptance value (L1) is declared not more than (NMT) 15; therefore, meeting the limit will just imply that the lower the value the higher the d...

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Publicado en:Pharmaceutical Technology Europe Vol. 36; no. 2; pp. 19 - 25
Formato: equations & formulas tables/charts Journal Article
Publicado: MJH Life Sciences Feb2024
Acceso en línea:Ver este registro en EBSCOhost