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PUBMED FOR HANDHELDS

Journal Abstract Search


289 related items for PubMed ID: 25358110

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  • 2. 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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  • 4. 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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  • 9. A quality by design approach for longitudinal quality attributes.
    Lebrun P, Giacoletti K, Scherder T, Rozet E, Boulanger B.
    J Biopharm Stat; 2015; 25(2):247-59. PubMed ID: 25360720
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  • 10. 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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  • 13. 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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  • 16. 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; 100(8):3031-3043. PubMed ID: 21425164
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  • 18. Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.
    Schepers U, El Deeb S, Ermer J, Wätzig H.
    J Pharm Biomed Anal; 2007 Jan 17; 43(2):708-10. PubMed ID: 16904281
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  • 19. Characterization and establishment of specifications for biopharmaceuticals.
    Davis GC, Riggin RM.
    Dev Biol Stand; 1997 Jan 17; 91():49-54. PubMed ID: 9413683
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