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PUBMED FOR HANDHELDS

Journal Abstract Search

1165 related items for PubMed ID: 19507321

  • 1. 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]

  • 2. 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]

  • 3. 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]

  • 4. 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]

  • 5. 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]

  • 6. 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]

  • 7. 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]

  • 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 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]

  • 10. 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]

  • 11. 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]

  • 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 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]

  • 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
    [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 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]

  • 16. 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]

  • 17. 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]

  • 18. 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]

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