These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

366 related articles for article (PubMed ID: 11067777)

  • 1. Pharmaceutical excipient development: the need for preclinical guidance.
    Baldrick P
    Regul Toxicol Pharmacol; 2000 Oct; 32(2):210-8. PubMed ID: 11067777
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A new approach to the safety assessment of pharmaceutical excipients. The Safety Committee of the International Pharmaceutical Excipients Council.
    Steinberg M; Borzelleca JF; Enters EK; Kinoshita FK; Loper A; Mitchell DB; Tamulinas CB; Weiner ML
    Regul Toxicol Pharmacol; 1996 Oct; 24(2 Pt 1):149-54. PubMed ID: 8933628
    [TBL] [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 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; 74(66):15992-3. PubMed ID: 19507323
    [TBL] [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; 74(6):908-9. PubMed ID: 20333832
    [TBL] [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; 74(245):68270-1. PubMed ID: 20344862
    [TBL] [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 7 on Dissolution Test General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Apr; 75(64):17148-9. PubMed ID: 20383923
    [TBL] [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 8 on Sterility Test General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Dec; 74(244):68068-9. PubMed ID: 20336863
    [TBL] [Abstract][Full Text] [Related]  

  • 8. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 9 on Tablet Friability General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Apr; 75(64):17147-8. PubMed ID: 20383922
    [TBL] [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 10 on Polyacrylamide Gel Electrophoresis General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Apr; 75(69):18509-10. PubMed ID: 20387318
    [TBL] [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 12 on Analytical Sieving General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2010 Sep; 75(170):53873-4. PubMed ID: 20812423
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances.
    Humfrey CD
    Toxicol Sci; 2007 Nov; 100(1):24-8. PubMed ID: 17656486
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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; 68(11):2339-40. PubMed ID: 12532979
    [TBL] [Abstract][Full Text] [Related]  

  • 13. The safety of chitosan as a pharmaceutical excipient.
    Baldrick P
    Regul Toxicol Pharmacol; 2010 Apr; 56(3):290-9. PubMed ID: 19788905
    [TBL] [Abstract][Full Text] [Related]  

  • 14. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2003 Feb; 68(28):6924-5. PubMed ID: 12583358
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Design and international harmonization of pharmacopoeial standards.
    Calam DH
    J Pharm Biomed Anal; 1995 Dec; 14(1-2):1-5. PubMed ID: 8833960
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.
    EFSA GMO Panel Working Group on Animal Feeding Trials
    Food Chem Toxicol; 2008 Mar; 46 Suppl 1():S2-70. PubMed ID: 18328408
    [TBL] [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 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Apr; 74(66):15991-2. PubMed ID: 19507322
    [TBL] [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; 74(66):15989-90. PubMed ID: 19507320
    [TBL] [Abstract][Full Text] [Related]  

  • 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; 74(109):27325-6. PubMed ID: 19588572
    [TBL] [Abstract][Full Text] [Related]  

  • 20. International Conference on Harmonisation; guidance on Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2000 Dec; 65(251):83041-63. PubMed ID: 12356095
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 19.