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Journal Abstract Search

136 related items for PubMed ID: 25358029

  • 1. A statistical approach to determining criticality of residual host cell DNA.
    Yang H, Wei Z, Schenerman M.
    J Biopharm Stat; 2015; 25(2):234-46. PubMed ID: 25358029
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  • 2. Guest editors' note: special issue on recent developments in statistical approaches for chemistry and manufacturing control (CMC) and quality-by-design(QbD).
    Tsong Y, Yang H.
    J Biopharm Stat; 2015; 25(2):233. PubMed ID: 25437635
    [No Abstract] [Full Text] [Related]

  • 3. Statistical considerations in setting product specifications.
    Dong X, Tsong Y, Shen M.
    J Biopharm Stat; 2015; 25(2):280-94. PubMed ID: 25358110
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  • 5. Non-normal random effects models for immunogenicity assay cut point determination.
    Zhang J, Yu B, Zhang L, Roskos L, Richman L, Yang H.
    J Biopharm Stat; 2015; 25(2):295-306. PubMed ID: 25356500
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  • 6. 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; 25(2):260-8. PubMed ID: 25357001
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  • 10. 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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  • 11. Testing assay linearity over a pre-specified range.
    Yang H, Novick SJ, LeBlond D.
    J Biopharm Stat; 2015; 25(2):339-50. PubMed ID: 25356663
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  • 12. A direct qPCR method for residual DNA quantification in monoclonal antibody drugs produced in CHO cells.
    Hussain M.
    J Pharm Biomed Anal; 2015 Nov 10; 115():603-6. PubMed ID: 25850374
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  • 14. A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.
    Martin-Moe S, Lim FJ, Wong RL, Sreedhara A, Sundaram J, Sane SU.
    J Pharm Sci; 2011 Aug 10; 100(8):3031-3043. PubMed ID: 21425164
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  • 15. Optimization and validation of DNA extraction and real-time PCR assay for the quantitative measurement of residual host cell DNA in biopharmaceutical products.
    Hu B, Sellers J, Kupec J, Ngo W, Fenton S, Yang TY, Grebanier A.
    J Pharm Biomed Anal; 2014 Jan 10; 88():92-5. PubMed ID: 24042121
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  • 16. A probabilistic model for risk assessment of residual host cell DNA in biological products.
    Yang H, Zhang L, Galinski M.
    Vaccine; 2010 Apr 26; 28(19):3308-11. PubMed ID: 20226252
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  • 18. Specific detection of residual CHO host cell DNA by real-time PCR.
    Nissom PM.
    Biologicals; 2007 Jun 26; 35(3):211-5. PubMed ID: 17071102
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  • 19. Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions.
    Hassett B, Singh E, Mahgoub E, O'Brien J, Vicik SM, Fitzpatrick B.
    MAbs; 2018 Jan 26; 10(1):159-165. PubMed ID: 29020515
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  • 20. Safety assessment of Madin Darby canine kidney cells as vaccine substrate.
    Medema JK, Meijer J, Kersten AJ, Horton R.
    Dev Biol (Basel); 2006 Jan 26; 123():243-50; discussion 265-6. PubMed ID: 16566450
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