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Journal Abstract Search

207 related items for PubMed ID: 25356617

  • 1. Using tolerance intervals for assessment of pharmaceutical quality.
    Dong X, Tsong Y, Shen M, Zhong J.
    J Biopharm Stat; 2015; 25(2):317-27. PubMed ID: 25356617
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  • 2. Quality assurance test of delivered dose uniformity of multiple-dose inhaler and dry powder inhaler drug products.
    Tsong Y, Dong X, Shen M, Lostritto RT.
    J Biopharm Stat; 2015; 25(2):328-38. PubMed ID: 25357132
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  • 7. One- and two-stage Arrhenius models for pharmaceutical shelf life prediction.
    Fan Z, Zhang L.
    J Biopharm Stat; 2015; 25(2):307-16. PubMed ID: 25358076
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  • 8. Sample sizes for batch acceptance from single- and multistage designs using two-sided normal tolerance intervals with specified content.
    Hauck WW, Shaikh R.
    J Biopharm Stat; 2001 Nov; 11(4):335-46. PubMed ID: 12018783
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  • 9. A quality by design approach for longitudinal quality attributes.
    Lebrun P, Giacoletti K, Scherder T, Rozet E, Boulanger B.
    J Biopharm Stat; 2015 Nov; 25(2):247-59. PubMed ID: 25360720
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  • 10. Estimation of the probability of passing the USP dissolution test.
    Wang H.
    J Biopharm Stat; 2007 Nov; 17(3):407-13. PubMed ID: 17479390
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  • 11. Analytical procedure validation and the quality by design paradigm.
    Rozet E, Lebrun P, Michiels JF, Sondag P, Scherder T, Boulanger B.
    J Biopharm Stat; 2015 Nov; 25(2):260-8. PubMed ID: 25357001
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  • 12. Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay.
    Shen M, Dong X, Tsong Y.
    J Biopharm Stat; 2015 Nov; 25(2):269-79. PubMed ID: 25356783
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  • 17. Acceptance Probability (P a) Analysis for Process Validation Lifecycle Stages.
    Alsmeyer D, Pazhayattil A, Chen S, Munaretto F, Hye M, Sanghvi P.
    AAPS PharmSciTech; 2016 Apr; 17(2):516-22. PubMed ID: 26024723
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  • 18. Validation of analytical methods involved in dissolution assays: acceptance limits and decision methodologies.
    Rozet E, Ziemons E, Marini RD, Boulanger B, Hubert P.
    Anal Chim Acta; 2012 Nov 02; 751():44-51. PubMed ID: 23084050
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  • 19. Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products.
    Montes RO, Burdick RK, Leblond DJ.
    PDA J Pharm Sci Technol; 2019 Nov 02; 73(1):39-59. PubMed ID: 30361286
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  • 20. Parametric two-stage sequential quality assurance test of dose content uniformity.
    Tsong Y, Shen M.
    J Biopharm Stat; 2007 Nov 02; 17(1):143-57. PubMed ID: 17219760
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