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PUBMED FOR HANDHELDS

Journal Abstract Search


624 related items for PubMed ID: 12358039

  • 21.
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  • 22. 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
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  • 24. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Apr 08; 74(66):15991-2. PubMed ID: 19507322
    [Abstract] [Full Text] [Related]

  • 25. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4B on Microbiological Examination of nonsterile products: Tests for Specified Microorganisms General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Apr 08; 74(66):15989-90. PubMed ID: 19507320
    [Abstract] [Full Text] [Related]

  • 26. 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]

  • 27. 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]

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  • 31. 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]

  • 32. 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 21; 75(13):3471-2. PubMed ID: 20349552
    [Abstract] [Full Text] [Related]

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  • 37. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8 on Sterility Test General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Dec 22; 74(244):68068-9. PubMed ID: 20336863
    [Abstract] [Full Text] [Related]

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  • 40. 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]


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