Literature DB >> 35035309

Intra-Lot and Inter-Lot Variability in Cosyntropin.

Philip J Almeter1,2, James T Isaacs1, Aaron N Hunter1, Bradley S Henderson1, Robert A Lodder3.   

Abstract

Intra-lot and inter-lot variability in cosyntropin was detected in the DQS using Fourier transform near-infrared spectrometry. One vial of 12 sampled from Sandoz Lot0200062 appeared 6.9 SDs from the center of the rest of the vials, and another was 4.3 SDs away. Spectra of 102 vials from 7 lots in the library clustered in two groups (p=0.02).

Entities:  

Year:  2021        PMID： 35035309      PMCID： PMC8758055          DOI： 10.6084/m9.figshare.17363048

Source DB:  PubMed          Journal:  Contact Context        ISSN： 1547-8890


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Review 1.  Principal component analysis: a review and recent developments.

Authors:  Ian T Jolliffe; Jorge Cadima
Journal:  Philos Trans A Math Phys Eng Sci       Date:  2016-04-13       Impact factor: 4.226
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Review 1.  FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply.

Authors:  Philip J Almeter; James T Isaacs; Aaron N Hunter; Bradley S Henderson; Thomas Platt; Billie J Mitchell; David Do; Alyssa B Brainard; Joshua E Brown; Rachael M Stone; Bao-Han Nguyen; Matthew F Warren; Smaran A Bhaktawara; Megan N Bossle; Lindsey M Long; Stephanie P Zapata; Cinnamon R Larkin; Thomas A Lyman; Seth A Larkin; Jonathan A Labuhn; Jeffrey W Reynolds; Erin E Schuler; Ryan W Naseman; Gary L Johnson; Robert A Lodder
Journal:  J Pharm Innov       Date:  2022-06-03       Impact factor: 2.538
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