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)

  • 21. International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.
    Fed Regist; 1998 Sep; 63(185):51074-84. PubMed ID: 10185809
    [TBL] [Abstract][Full Text] [Related]  

  • 22. [Preclinical evaluation of the safety of biotechnology products: specific aspects].
    Descotes J; Ravel G; Vial T
    Therapie; 2003; 58(2):139-43. PubMed ID: 12942854
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.
    Cavagnaro J; Silva Lima B
    Eur J Pharmacol; 2015 Jul; 759():51-62. PubMed ID: 25814257
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Current guidelines for the preclinical safety assessment of therapeutic proteins.
    Bass R; Kleeberg U; Schröder H; Scheibner E
    Toxicol Lett; 1992 Dec; 64-65 Spec No():339-47. PubMed ID: 1471190
    [TBL] [Abstract][Full Text] [Related]  

  • 25. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.
    Food and Drug Administration, HHS
    Fed Regist; 2016 Jun; 81(121):40890-1. PubMed ID: 27373012
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Recommendations for safety pharmacology evaluations of oligonucleotide-based therapeutics.
    Berman CL; Cannon K; Cui Y; Kornbrust DJ; Lagrutta A; Sun SZ; Tepper J; Waldron G; Younis HS
    Nucleic Acid Ther; 2014 Aug; 24(4):291-301. PubMed ID: 24946015
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals.
    Buckley LA; Chapman K; Burns-Naas LA; Todd MD; Martin PL; Lansita JA
    Int J Toxicol; 2011 Oct; 30(5):583-90. PubMed ID: 22013138
    [TBL] [Abstract][Full Text] [Related]  

  • 28. International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1999 Aug; 64(159):44928-35. PubMed ID: 12356094
    [TBL] [Abstract][Full Text] [Related]  

  • 29. ICH-harmonised guidances on genotoxicity testing of pharmaceuticals: evolution, reasoning and impact.
    Müller L; Kikuchi Y; Probst G; Schechtman L; Shimada H; Sofuni T; Tweats D
    Mutat Res; 1999 May; 436(3):195-225. PubMed ID: 10354523
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.
    Roberts SA; Andrews PA; Blanset D; Flagella KM; Gorovits B; Lynch CM; Martin PL; Kramer-Stickland K; Thibault S; Warner G
    Regul Toxicol Pharmacol; 2013 Dec; 67(3):382-91. PubMed ID: 24012707
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics.
    Vargas HM; Bass AS; Breidenbach A; Feldman HS; Gintant GA; Harmer AR; Heath B; Hoffmann P; Lagrutta A; Leishman D; McMahon N; Mittelstadt S; Polonchuk L; Pugsley MK; Salata JJ; Valentin JP
    J Pharmacol Toxicol Methods; 2008; 58(2):72-6. PubMed ID: 18508287
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.
    Li K; Rogers G; Nashed-Samuel Y; Lee H; Mire-Sluis A; Cherney B; Forster R; Yeh P; Markovic I
    PDA J Pharm Sci Technol; 2015; 69(5):590-619. PubMed ID: 26429108
    [TBL] [Abstract][Full Text] [Related]  

  • 33. International Conference on Harmonisation; guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human Use; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2012 Jun; 77(110):33748-9. PubMed ID: 22675782
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.
    Beken S; Kasper P; van der Laan JW
    Adv Exp Med Biol; 2016; 856():33-64. PubMed ID: 27671719
    [TBL] [Abstract][Full Text] [Related]  

  • 35. 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]  

  • 36. Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.
    Brennan FR; Andrews L; Arulanandam AR; Blumel J; Fikes J; Grimaldi C; Lansita J; Loberg LI; MacLachlan T; Milton M; Parker S; Tibbitts J; Wolf J; Allamneni KP
    Regul Toxicol Pharmacol; 2018 Oct; 98():98-107. PubMed ID: 30026135
    [TBL] [Abstract][Full Text] [Related]  

  • 37. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].
    Lehmann J; Schulz RM; Sanzenbacher R
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1215-24. PubMed ID: 26431722
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Issues with biotechnology products in toxicologic pathology.
    Terrell TG; Green JD
    Toxicol Pathol; 1994; 22(2):187-93. PubMed ID: 7973366
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer.
    Senderowicz AM
    Clin Cancer Res; 2010 Mar; 16(6):1719-25. PubMed ID: 20215544
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Quality management of pharmacology and safety pharmacology studies.
    Spindler P; Seiler JP
    Fundam Clin Pharmacol; 2002 Apr; 16(2):83-90. PubMed ID: 12031061
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 45.