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Journal Abstract Search

462 related items for PubMed ID: 19345250

  • 21. Immunogenicity assessment in non-clinical studies.
    Swanson SJ, Bussiere J.
    Curr Opin Microbiol; 2012 Jun; 15(3):337-47. PubMed ID: 22770538
    [Abstract] [Full Text] [Related]

  • 22. Interpretation and considerations on the safety evaluation of human drug metabolites.
    Atrakchi AH.
    Chem Res Toxicol; 2009 Jul; 22(7):1217-20. PubMed ID: 19563206
    [Abstract] [Full Text] [Related]

  • 23. Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s.
    Powley MW, Frederick CB, Sistare FD, DeGeorge JJ.
    Chem Res Toxicol; 2009 Feb; 22(2):257-62. PubMed ID: 19170595
    [Abstract] [Full Text] [Related]

  • 24. What have we learned from pre-clinical juvenile toxicity studies?
    Bailey GP, Mariën D.
    Reprod Toxicol; 2009 Sep; 28(2):226-9. PubMed ID: 19446432
    [Abstract] [Full Text] [Related]

  • 25. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
    Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A.
    J Immunol Methods; 2008 Apr 20; 333(1-2):1-9. PubMed ID: 18275969
    [Abstract] [Full Text] [Related]

  • 26. The challenges of immunogenicity in developing biosimilar products.
    Wadhwa M, Thorpe R.
    IDrugs; 2009 Jul 20; 12(7):440-4. PubMed ID: 19579165
    [Abstract] [Full Text] [Related]

  • 27. Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop.
    Buckley LA, Benson K, Davis-Bruno K, Dempster M, Finch GL, Harlow P, Haggerty HG, Hart T, Kinter L, Leighton JK, McNulty J, Roskos L, Saber H, Stauber A, Tabrizi M.
    Int J Toxicol; 2008 Jul 20; 27(4):303-12. PubMed ID: 18821393
    [Abstract] [Full Text] [Related]

  • 28. Direct dosing of preweaning rodents in toxicity testing and research: deliberations of an ILSI RSI Expert Working Group.
    Moser VC, Walls I, Zoetis T.
    Int J Toxicol; 2005 Jul 20; 24(2):87-94. PubMed ID: 16036767
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  • 29. Preclinical efficacy and safety models for mAbs: the challenge of developing effective model systems.
    Dixit R, Coats S.
    IDrugs; 2009 Feb 20; 12(2):103-8. PubMed ID: 19204884
    [Abstract] [Full Text] [Related]

  • 30. Assessment of diurnal systemic dose of agrochemicals in regulatory toxicity testing--an integrated approach without additional animal use.
    Saghir SA, Bartels MJ, Rick DL, McCoy AT, Rasoulpour RJ, Ellis-Hutchings RG, Sue Marty M, Terry C, Bailey JP, Billington R, Bus JS.
    Regul Toxicol Pharmacol; 2012 Jul 20; 63(2):321-32. PubMed ID: 22440553
    [Abstract] [Full Text] [Related]

  • 31. Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards.
    Vishwanathan K, Babalola K, Wang J, Espina R, Yu L, Adedoyin A, Talaat R, Mutlib A, Scatina J.
    Chem Res Toxicol; 2009 Feb 20; 22(2):311-22. PubMed ID: 19067650
    [Abstract] [Full Text] [Related]

  • 32. Preclinical evaluation of juvenile toxicity.
    Barrow PC, Barbellion S, Stadler J.
    Methods Mol Biol; 2011 Feb 20; 691():17-35. PubMed ID: 20972745
    [Abstract] [Full Text] [Related]

  • 33. Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices.
    Morford LL, Bowman CJ, Blanset DL, Bøgh IB, Chellman GJ, Halpern WG, Weinbauer GF, Coogan TP.
    Birth Defects Res B Dev Reprod Toxicol; 2011 Aug 20; 92(4):359-80. PubMed ID: 21770023
    [Abstract] [Full Text] [Related]

  • 34. Single dose toxicity and repeated dose toxicity studies: introductory remarks.
    Kurokawa Y, Matsuzawa T.
    J Toxicol Sci; 1996 Dec 20; 21(5):413-6. PubMed ID: 9035047
    [No Abstract] [Full Text] [Related]

  • 35. Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?
    Clarke J, Hurst C, Martin P, Vahle J, Ponce R, Mounho B, Heidel S, Andrews L, Reynolds T, Cavagnaro J.
    Regul Toxicol Pharmacol; 2008 Feb 20; 50(1):2-22. PubMed ID: 17998153
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  • 36. Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins.
    van Beers MM, Bardor M.
    Biotechnol J; 2012 Dec 20; 7(12):1473-84. PubMed ID: 23027660
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  • 37. An FDA perspective on the nonclinical use of the X-Omics technologies and the safety of new drugs.
    Jacobs A.
    Toxicol Lett; 2009 Apr 10; 186(1):32-5. PubMed ID: 18809476
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  • 38. Optimising the design of preliminary toxicity studies for pharmaceutical safety testing in the dog.
    Smith D, Combes R, Depelchin O, Jacobsen SD, Hack R, Luft J, Lammens L, von Landenberg F, Phillips B, Pfister R, Rabemampianina Y, Sparrow S, Stark C, Stephan-Gueldner M.
    Regul Toxicol Pharmacol; 2005 Mar 10; 41(2):95-101. PubMed ID: 15698532
    [Abstract] [Full Text] [Related]

  • 39. Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals.
    Tibbitts J, Cavagnaro JA, Haller CA, Marafino B, Andrews PA, Sullivan JT.
    Regul Toxicol Pharmacol; 2010 Nov 10; 58(2):243-51. PubMed ID: 20558225
    [Abstract] [Full Text] [Related]

  • 40. Evaluation of the cynomolgus monkey stomach: recommendations for standard sampling procedures in nonclinical safety studies.
    Vidal JD, Mirabile RC, Thomas HC.
    Toxicol Pathol; 2008 Feb 10; 36(2):250-5. PubMed ID: 18364462
    [Abstract] [Full Text] [Related]

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