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Journal Abstract Search

850 related items for PubMed ID: 12325111

  • 1. Industry perspectives on ICH guidelines.
    Rockhold FW.
    Stat Med; 2002 Oct 15; 21(19):2949-57. PubMed ID: 12325111
    [Abstract] [Full Text] [Related]

  • 2. 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 15; 4(4):240-6. PubMed ID: 8890349
    [Abstract] [Full Text] [Related]

  • 3. [Objectives and organization of the International Conference on Harmonization].
    Juillet Y.
    Ann Pharm Fr; 1999 Mar 15; 57(2):137-42. PubMed ID: 10365469
    [Abstract] [Full Text] [Related]

  • 4. 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; 1999 Mar 15; 14(9-10):117-27. PubMed ID: 7569506
    [Abstract] [Full Text] [Related]

  • 5. International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 Oct 16; 66(200):52634-7. PubMed ID: 12358037
    [Abstract] [Full Text] [Related]

  • 6. Regulatory advice and drug development--a case study in negotiating with regulators.
    Seldrup J.
    Stat Med; 2011 Jun 15; 30(13):1628-35. PubMed ID: 21365671
    [Abstract] [Full Text] [Related]

  • 7. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Apr 08; 74(66):15990-1. PubMed ID: 19507321
    [Abstract] [Full Text] [Related]

  • 8. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2015 Jan 27; 80(17):4282-3. PubMed ID: 25730921
    [Abstract] [Full Text] [Related]

  • 9. 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 21; 73(35):9575-6. PubMed ID: 18677819
    [Abstract] [Full Text] [Related]

  • 10. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M, Bertram D.
    Arch Pediatr; 2014 Oct 21; 21(10):1129-38. PubMed ID: 25175054
    [Abstract] [Full Text] [Related]

  • 11. 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 21; 89(4):503-12. PubMed ID: 21326288
    [Abstract] [Full Text] [Related]

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  • 13. 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 18; 77(97):29665-6. PubMed ID: 22616137
    [Abstract] [Full Text] [Related]

  • 14.
    ; . PubMed ID:
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  • 15. [Our policy and future tasks related to ICH in anti-cancer drug development--a discussion from the viewpoint of an enterprise].
    Ekimoto H.
    Gan To Kagaku Ryoho; 1997 Jan 18; 24(2):229-37. PubMed ID: 9030236
    [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; Annex 4C on Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Apr 08; 74(66):15992-3. PubMed ID: 19507323
    [Abstract] [Full Text] [Related]

  • 17. International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2006 Jun 02; 71(106):32105-6. PubMed ID: 16795933
    [Abstract] [Full Text] [Related]

  • 18. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).
    Bahri P, Tsintis P.
    Pharmacoepidemiol Drug Saf; 2005 Jun 02; 14(6):377-87. PubMed ID: 15517542
    [Abstract] [Full Text] [Related]

  • 19. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
    Reeve LM.
    Regul Toxicol Pharmacol; 2009 Nov 02; 55(2):181-7. PubMed ID: 19589365
    [Abstract] [Full Text] [Related]

  • 20. ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.
    Prescrire Int; 2010 Aug 02; 19(108):183-6. PubMed ID: 20939460
    [Abstract] [Full Text] [Related]

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