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Journal Abstract Search

546 related items for PubMed ID: 22616137

  • 1. International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2012 May 18; 77(97):29665-6. PubMed ID: 22616137
    [Abstract] [Full Text] [Related]

  • 2. International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 Jul 13; 66(135):36791-2. PubMed ID: 12356097
    [Abstract] [Full Text] [Related]

  • 3. 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]

  • 4. International Conference on Harmonisation; guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human Use; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2012 Jun 07; 77(110):33748-9. PubMed ID: 22675782
    [Abstract] [Full Text] [Related]

  • 5. 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]

  • 6. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2015 Jan 27; 80(17):4282-3. PubMed ID: 25730921
    [Abstract] [Full Text] [Related]

  • 7. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2001 May 14; 66(93):24390-1. PubMed ID: 12356096
    [Abstract] [Full Text] [Related]

  • 8. 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
    [Abstract] [Full Text] [Related]

  • 9. 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]

  • 10. International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Apr 02; 68(63):16060-1. PubMed ID: 12674113
    [Abstract] [Full Text] [Related]

  • 11. 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]

  • 12. International Conference on Harmonisation; Guidance on S9 Nonclincal Evaluation for Anticancer Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2010 Mar 08; 75(44):10487-8. PubMed ID: 20383918
    [Abstract] [Full Text] [Related]

  • 13. 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]

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  • 19. 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]

  • 20. 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]

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