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PUBMED FOR HANDHELDS

Journal Abstract Search


337 related items for PubMed ID: 16904281

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  • 4. [Technical implications on the quality standard of new drugs].
    Uchiyama M.
    Eisei Shikenjo Hokoku; 1995; (113):135-6. PubMed ID: 8717247
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  • 5. 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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  • 6. Use of a quality-by-design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols.
    Skrdla PJ, Wang T, Antonucci V, Dowling T, Ge Z, Ellison D, Curran J, Mohan G, Wyvratt J.
    J Pharm Biomed Anal; 2009 Dec 05; 50(5):794-6. PubMed ID: 19596534
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  • 9. A new approach to evaluate regression models during validation of bioanalytical assays.
    Singtoroj T, Tarning J, Annerberg A, Ashton M, Bergqvist Y, White NJ, Lindegardh N, Day NP.
    J Pharm Biomed Anal; 2006 Apr 11; 41(1):219-27. PubMed ID: 16332425
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  • 11. Analytical method transfer: new descriptive approach for acceptance criteria definition.
    de Fontenay G.
    J Pharm Biomed Anal; 2008 Jan 07; 46(1):104-12. PubMed ID: 17961955
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  • 14. Design and analysis of method equivalence studies.
    Borman PJ, Chatfield MJ, Damjanov I, Jackson P.
    Anal Chem; 2009 Dec 15; 81(24):9849-57. PubMed ID: 19925005
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  • 15. [Observations on the specifics in the quality of drugs].
    Setnikar I.
    Boll Chim Farm; 1968 Mar 15; 107(3):158-67. PubMed ID: 5730323
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  • 16. A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.
    Yang H, Zhang J.
    PDA J Pharm Sci Technol; 2015 Mar 15; 69(6):725-35. PubMed ID: 26659103
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  • 17. 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 Mar 15; 25(2):233. PubMed ID: 25437635
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  • 20. Discriminatory power of the different requirements for uniformity of dosage units in the European pharmacopoeia.
    Limberg J, Savsek M.
    Pharmeur Sci Notes; 2006 Dec 15; 2006(2):45-8. PubMed ID: 17691214
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