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PUBMED FOR HANDHELDS

Journal Abstract Search


615 related items for PubMed ID: 12358036

  • 1. 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
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  • 3. 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
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  • 5. 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]

  • 6. International Conference on Harmonisation; guidance on E2E Pharmacovigilance Planning; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2005 Apr 01; 70(62):16827-8. PubMed ID: 15803631
    [Abstract] [Full Text] [Related]

  • 7. 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
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  • 10. 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
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  • 14. 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]

  • 15. 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]

  • 16. 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]

  • 17. 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
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