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Journal Abstract Search

835 related items for PubMed ID: 19507323

  • 1. 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]

  • 2. 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]

  • 3. 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]

  • 4. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Test for Extractable Volume of Parenteral Preparations General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Jan 09; 74(6):908-9. PubMed ID: 20333832
    [Abstract] [Full Text] [Related]

  • 5. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 5 on Disintegration Test General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Dec 23; 74(245):68270-1. PubMed ID: 20344862
    [Abstract] [Full Text] [Related]

  • 6. 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]

  • 7. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7 on Dissolution Test General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2010 Apr 05; 75(64):17148-9. PubMed ID: 20383923
    [Abstract] [Full Text] [Related]

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  • 9. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial texts for use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2010 Sep 02; 75(170):53873-4. PubMed ID: 20812423
    [Abstract] [Full Text] [Related]

  • 10. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 10 on Polyacrylamide Gel Electrophoresis General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2010 Apr 12; 75(69):18509-10. PubMed ID: 20387318
    [Abstract] [Full Text] [Related]

  • 11. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Feb 21; 73(35):9576-7. PubMed ID: 18677820
    [Abstract] [Full Text] [Related]

  • 12. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Test for Particulate Contamination: Subvisible Particles General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Jan 09; 74(6):909-10. PubMed ID: 20336864
    [Abstract] [Full Text] [Related]

  • 13. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2013 May 28; 78(102):31944-5. PubMed ID: 23724425
    [Abstract] [Full Text] [Related]

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  • 15. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6 on Uniformity of Dosage Units General Chapter; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2014 Jun 16; 79(115):34314-5. PubMed ID: 25011159
    [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 21; 73(35):9575-6. PubMed ID: 18677819
    [Abstract] [Full Text] [Related]

  • 17. International Conference on Harmonisation; draft guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Disintegration Test General Chapter; availability. Notice.
    Fed Regist; 2008 Aug 05; 73(151):45466-7. PubMed ID: 18956490
    [No Abstract] [Full Text] [Related]

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  • 19. 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]

  • 20. 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]

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