These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

101 related articles for article (PubMed ID: 9080714)

  • 1. Overcoming obstacles to monoclonal antibody product development and approval.
    Stein KE
    Trends Biotechnol; 1997 Mar; 15(3):88-90. PubMed ID: 9080714
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Preclinical and clinical safety of monoclonal antibodies.
    Tabrizi MA; Roskos LK
    Drug Discov Today; 2007 Jul; 12(13-14):540-7. PubMed ID: 17631248
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Regulatory agency concerns in the manufacturing and testing of monoclonal antibodies for therapeutic use.
    Baker DA; Harkonen WS
    Targeted Diagn Ther; 1990; 3():75-98. PubMed ID: 2131019
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Development and regulation of monoclonal antibody products: challenges and opportunities.
    Weinberg WC; Frazier-Jessen MR; Wu WJ; Weir A; Hartsough M; Keegan P; Fuchs C
    Cancer Metastasis Rev; 2005 Dec; 24(4):569-84. PubMed ID: 16408162
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Cumulative updating of approved biopharmaceuticals.
    Redwan el-RM
    Hum Antibodies; 2007; 16(3-4):137-58. PubMed ID: 18334749
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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; 58(2):243-51. PubMed ID: 20558225
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Aggregates in monoclonal antibody manufacturing processes.
    Vázquez-Rey M; Lang DA
    Biotechnol Bioeng; 2011 Jul; 108(7):1494-508. PubMed ID: 21480193
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Translational strategies for development of monoclonal antibodies from discovery to the clinic.
    Tabrizi MA; Bornstein GG; Klakamp SL; Drake A; Knight R; Roskos L
    Drug Discov Today; 2009 Mar; 14(5-6):298-305. PubMed ID: 19152840
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Human antibodies from transgenic animals.
    Lonberg N
    Nat Biotechnol; 2005 Sep; 23(9):1117-25. PubMed ID: 16151405
    [TBL] [Abstract][Full Text] [Related]  

  • 10. [Brief overview on the studies of monoclonal antibody].
    Tsukagoshi S
    Nihon Rinsho; 2002 Mar; 60(3):435-8. PubMed ID: 11904954
    [TBL] [Abstract][Full Text] [Related]  

  • 11. FDA perspective on specifications for biotechnology products--from IND to PLA.
    Murano G
    Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Hazard identification and risk assessment for biologics targeting the immune system.
    Weir AB
    J Immunotoxicol; 2008 Jan; 5(1):3-10. PubMed ID: 18382852
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies.
    Putnam WS; Prabhu S; Zheng Y; Subramanyam M; Wang YM
    Trends Biotechnol; 2010 Oct; 28(10):509-16. PubMed ID: 20691488
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Preclinical safety evaluation of monoclonal antibodies.
    Lynch CM; Grewal IS
    Handb Exp Pharmacol; 2008; (181):19-44. PubMed ID: 18071940
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Clinical trials of gene/biotechnology products.
    Röthig HJ
    Methods Find Exp Clin Pharmacol; 1994 Sep; 16(7):539-44. PubMed ID: 7885081
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Nimotuzumab: a novel anti-EGFR monoclonal antibody that retains anti-EGFR activity while minimizing skin toxicity.
    Boland WK; Bebb G
    Expert Opin Biol Ther; 2009 Sep; 9(9):1199-206. PubMed ID: 19624281
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Comparative requirements for exploratory clinical trials -- eIND, eCTA and microdosing.
    Muller PY
    Adv Drug Deliv Rev; 2011 Jun; 63(7):511-7. PubMed ID: 21034787
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The therapeutic antibodies market to 2008.
    Pavlou AK; Belsey MJ
    Eur J Pharm Biopharm; 2005 Apr; 59(3):389-96. PubMed ID: 15760719
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Using partition designs to enhance purification process understanding.
    Pieracci J; Perry L; Conley L
    Biotechnol Bioeng; 2010 Dec; 107(5):814-24. PubMed ID: 20632374
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Criteria for investigation of the product equivalence of monoclonal antibodies for therapeutic and in vivo-diagnostic use in case of introduction of changes in the manufacturing process.
    Schäffner G; Haase M; Giess S
    Biologicals; 1995 Sep; 23(3):253-9. PubMed ID: 8527127
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 6.