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Journal Abstract Search

463 related items for PubMed ID: 16612859

  • 1. 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]

  • 2. International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2005 Oct 20; 70(202):61133-4. PubMed ID: 16237859
    [Abstract] [Full Text] [Related]

  • 3. 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]

  • 4. 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]

  • 5. 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]

  • 6. 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]

  • 7. 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]

  • 8. International Conference on Harmonisation; guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing); availability. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1999 Jun 25; 64(122):34259-60. PubMed ID: 12356093
    [Abstract] [Full Text] [Related]

  • 9. 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]

  • 10. 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]

  • 11. 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]

  • 12. 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]

  • 13. 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]

  • 14. 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]

  • 15. 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]

  • 16. International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2002 Jan 04; 67(3):603-5. PubMed ID: 12365425
    [Abstract] [Full Text] [Related]

  • 17. 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]

  • 18. 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]

  • 19. International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1998 Feb 23; 63(35):8983-6. PubMed ID: 12269370
    [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 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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