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 *

285 related articles for article (PubMed ID: 20045015)

  • 1. Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.
    Rosenfeldt H; Kropp T; Benson K; Ricci MS; McGuinn WD; Verbois SL
    Toxicol Appl Pharmacol; 2010 Mar; 243(2):125-33. PubMed ID: 20045015
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization.
    O'Neill RT
    Stat Med; 1995 May 15-30; 14(9-10):117-27. PubMed ID: 7569506
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2011 Aug; 76(163):52667-8. PubMed ID: 21894658
    [TBL] [Abstract][Full Text] [Related]  

  • 5. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Aug; 73(151):45462-3. PubMed ID: 18949880
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Industry perspectives on ICH guidelines.
    Rockhold FW
    Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
    [TBL] [Abstract][Full Text] [Related]  

  • 7. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2004 Feb; 69(24):5551-2. PubMed ID: 14968802
    [TBL] [Abstract][Full Text] [Related]  

  • 8. International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2001 Oct; 66(200):52634-7. PubMed ID: 12358037
    [TBL] [Abstract][Full Text] [Related]  

  • 9. International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1998 Jan; 63(10):2396-404. PubMed ID: 12296373
    [TBL] [Abstract][Full Text] [Related]  

  • 10. ICH S9: Developing anticancer drugs, one year later.
    Ponce R
    Toxicol Pathol; 2011 Oct; 39(6):913-5. PubMed ID: 21859887
    [TBL] [Abstract][Full Text] [Related]  

  • 11. International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2002 Jan; 67(3):603-5. PubMed ID: 12365425
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Economics of new oncology drug development.
    DiMasi JA; Grabowski HG
    J Clin Oncol; 2007 Jan; 25(2):209-16. PubMed ID: 17210942
    [TBL] [Abstract][Full Text] [Related]  

  • 13. The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.
    Cocchetto DM
    Qual Assur; 1995 Dec; 4(4):240-6. PubMed ID: 8890349
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
    [TBL] [Abstract][Full Text] [Related]  

  • 15. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.
    Molzon JA; Giaquinto A; Lindstrom L; Tominaga T; Ward M; Doerr P; Hunt L; Rago L
    Clin Pharmacol Ther; 2011 Apr; 89(4):503-12. PubMed ID: 21326288
    [TBL] [Abstract][Full Text] [Related]  

  • 16. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Feb; 73(35):9575-6. PubMed ID: 18677819
    [TBL] [Abstract][Full Text] [Related]  

  • 17. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Jan; 75(13):3471-2. PubMed ID: 20349552
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline.
    Darpo B; Nebout T; Sager PT
    J Clin Pharmacol; 2006 May; 46(5):498-507. PubMed ID: 16638733
    [TBL] [Abstract][Full Text] [Related]  

  • 19. International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2005 Oct; 70(202):61133-4. PubMed ID: 16237859
    [TBL] [Abstract][Full Text] [Related]  

  • 20. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2002 Jan; 67(3):602-3. PubMed ID: 12358039
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 15.