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Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

521 related items for PubMed ID: 14968802

  • 1. 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
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  • 3. International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2011 Aug 23; 76(163):52667-8. PubMed ID: 21894658
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  • 6. International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1998 Jan 15; 63(10):2396-404. PubMed ID: 12296373
    [Abstract] [Full Text] [Related]

  • 7. 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]

  • 8. 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]

  • 9. 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]

  • 10. 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
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  • 12. 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
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  • 13. 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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  • 15. 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
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  • 17. 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]

  • 18. 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]

  • 19. 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
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