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Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

588 related items for PubMed ID: 15988855

  • 1. International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2005 Jun 30; 70(125):37861-2. PubMed ID: 15988855
    [Abstract] [Full Text] [Related]

  • 2. International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 Sep 25; 66(186):49028-9. PubMed ID: 12358036
    [Abstract] [Full Text] [Related]

  • 3. 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 18; 64(159):44928-35. PubMed ID: 12356094
    [Abstract] [Full Text] [Related]

  • 4. International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1998 Sep 21; 63(182):50244-9. PubMed ID: 12269373
    [Abstract] [Full Text] [Related]

  • 5. 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 05; 69(24):5551-2. PubMed ID: 14968802
    [Abstract] [Full Text] [Related]

  • 6. 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]

  • 7. International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Nov 14; 68(220):64628-9. PubMed ID: 14619944
    [Abstract] [Full Text] [Related]

  • 8. International Conference on Harmonisation; evaluation of stability data; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2004 Jun 08; 69(110):32010-1. PubMed ID: 15185712
    [Abstract] [Full Text] [Related]

  • 9. International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Jan 16; 68(11):2339-40. PubMed ID: 12532979
    [Abstract] [Full Text] [Related]

  • 10. International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 Jul 13; 66(135):36791-2. PubMed ID: 12356097
    [Abstract] [Full Text] [Related]

  • 11. International Conference on Harmonisation; Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2006 Apr 13; 71(71):19193-4. PubMed ID: 16612859
    [Abstract] [Full Text] [Related]

  • 12. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Feb 11; 68(28):6924-5. PubMed ID: 12583358
    [Abstract] [Full Text] [Related]

  • 13. International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2006 May 22; 71(98):29344-5. PubMed ID: 16749216
    [Abstract] [Full Text] [Related]

  • 14. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Aug 05; 73(151):45462-3. PubMed ID: 18949880
    [Abstract] [Full Text] [Related]

  • 15. International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2012 Nov 20; 77(224):69634-5. PubMed ID: 23227566
    [Abstract] [Full Text] [Related]

  • 16. 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]

  • 17. International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 Nov 07; 66(216):56332-3. PubMed ID: 12358038
    [Abstract] [Full Text] [Related]

  • 18. International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Jun 09; 74(109):27325-6. PubMed ID: 19588572
    [Abstract] [Full Text] [Related]

  • 19. International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Apr 02; 68(63):16060-1. PubMed ID: 12674113
    [Abstract] [Full Text] [Related]

  • 20. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2000 Dec 15; 65(242):78493-4. PubMed ID: 12362934
    [Abstract] [Full Text] [Related]

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