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 *

889 related articles for article (PubMed ID: 10367669)

  • 1. Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.
    Serabian MA; Pilaro AM
    Toxicol Pathol; 1999; 27(1):27-31. PubMed ID: 10367669
    [TBL] [Abstract][Full Text] [Related]  

  • 2. "Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).
    Nakazawa T; Kai S; Kawai M; Maki E; Sagami F; Onodera H; Kitajima S; Inoue T
    J Toxicol Sci; 2004 Dec; 29(5):497-504. PubMed ID: 15729005
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Preclinical development strategies for novel gene therapeutic products.
    Pilaro AM; Serabian MA
    Toxicol Pathol; 1999; 27(1):4-7. PubMed ID: 10367665
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.
    EFSA GMO Panel Working Group on Animal Feeding Trials
    Food Chem Toxicol; 2008 Mar; 46 Suppl 1():S2-70. PubMed ID: 18328408
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.
    Snodin DJ; Ryle PR
    BioDrugs; 2006; 20(1):25-52. PubMed ID: 16573349
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products.
    Lewis RM; Cavagnaro J
    Biologicals; 2010 Jul; 38(4):494-500. PubMed ID: 20359910
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Metabolites in safety testing.
    Robison TW; Jacobs A
    Bioanalysis; 2009 Oct; 1(7):1193-200. PubMed ID: 21083045
    [TBL] [Abstract][Full Text] [Related]  

  • 8. International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2012 May; 77(97):29665-6. PubMed ID: 22616137
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example.
    Black LE; Bendele AM; Bendele RA; Zack PM; Hamilton M
    Toxicol Pathol; 1999; 27(1):22-6. PubMed ID: 10367668
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Nonclinical development of biopharmaceuticals.
    Baumann A
    Drug Discov Today; 2009 Dec; 14(23-24):1112-22. PubMed ID: 19853058
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Safety Pharmacology Evaluation of Biopharmaceuticals.
    Amouzadeh HR; Engwall MJ; Vargas HM
    Handb Exp Pharmacol; 2015; 229():385-404. PubMed ID: 26091648
    [TBL] [Abstract][Full Text] [Related]  

  • 12. International Conference on Harmonisation; Guidance on S9 Nonclincal Evaluation for Anticancer Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Mar; 75(44):10487-8. PubMed ID: 20383918
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance.
    Nakazawa T; Kurokawa M; Kimura K; Wakata A; Hisada S; Inoue T; Sagami F; Heidel SM; Kawakami K; Shinoda K; Onodera H; Kumagai Y; Ohno Y; Kawamura N; Yamazaki T; Inoue T
    J Toxicol Sci; 2008 Aug; 33(3):277-82. PubMed ID: 18670158
    [TBL] [Abstract][Full Text] [Related]  

  • 14. International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2011 Aug; 76(155):49773-4. PubMed ID: 21834216
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges.
    Brennan FR; Shaw L; Wing MG; Robinson C
    Mol Biotechnol; 2004 May; 27(1):59-74. PubMed ID: 15122047
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. The role of the toxicologic pathologist in the preclinical safety evaluation of biotechnology-derived pharmaceuticals.
    Pilling AM
    Toxicol Pathol; 1999; 27(6):678-88. PubMed ID: 10588549
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Use of the dog as non-rodent test species in the safety testing schedule associated with the registration of crop and plant protection products (pesticides): present status.
    Box RJ; Spielmann H
    Arch Toxicol; 2005 Nov; 79(11):615-26. PubMed ID: 15940470
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Nonclinical safety evaluation of biotechnologically derived pharmaceuticals.
    Dempster AM
    Biotechnol Annu Rev; 2000; 5():221-58. PubMed ID: 10875002
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Minimum safety requirements for preclinical testing.
    Dorner F; Barrett PN; Schwartz HP; Eibl H
    Dev Biol Stand; 1993; 81():245-52. PubMed ID: 8174809
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 45.