BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

276 related articles for article (PubMed ID: 22903309)

  • 21. 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]  

  • 22. Global regulatory standards for the approval of biosimilars.
    Mounho B; Phillips A; Holcombe K; Grampp G; Lubiniecki T; Mollerup I; Jones C
    Food Drug Law J; 2010; 65(4):819-37, ii-iii. PubMed ID: 24479248
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Clinical trial development for biosimilars.
    Alten R; Cronstein BN
    Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S2-8. PubMed ID: 26058550
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Nonclinical development of a biosimilar: the current landscape.
    O'Connor A; Rogge M
    Bioanalysis; 2013 Mar; 5(5):537-44. PubMed ID: 23425270
    [TBL] [Abstract][Full Text] [Related]  

  • 25. International Conference on Harmonisation; draft guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products--FDA. Notice.
    Fed Regist; 1998 Jun; 63(110):31506-13. PubMed ID: 10180131
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
    Alvarez DF; Wolbink G; Cronenberger C; Orazem J; Kay J
    BioDrugs; 2020 Dec; 34(6):723-732. PubMed ID: 32990892
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Statistical assessment of biosimilar products.
    Chow SC; Liu JP
    J Biopharm Stat; 2010 Jan; 20(1):10-30. PubMed ID: 20077246
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Improving the power to establish clinical similarity in a Phase 3 efficacy trial by incorporating prior evidence of analytical and pharmacokinetic similarity.
    Zeng D; Pan J; Hu K; Chi E; Lin DY
    J Biopharm Stat; 2018; 28(2):320-332. PubMed ID: 29173074
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Draft guidance for industry on developing medical imaging drugs and biologics; availability--FDA. Availability of guidance.
    Fed Regist; 1998 Oct; 63(198):55067-9. PubMed ID: 10185833
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Statistical methods for assessing interchangeability of biosimilars.
    Chow SC; Yang LY; Starr A; Chiu ST
    Stat Med; 2013 Feb; 32(3):442-8. PubMed ID: 22899372
    [TBL] [Abstract][Full Text] [Related]  

  • 31. A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products.
    Kimanani E; Stypinski D; Curtis G; Stiles M; Heessels P; Logan S; Nelson K; St Germain E; Boswell G
    J Clin Pharmacol; 2000 Oct; 40(10):1102-8. PubMed ID: 11028249
    [TBL] [Abstract][Full Text] [Related]  

  • 32. The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.
    Cocchetto DM
    Qual Assur; 1995 Dec; 4(4):240-6. PubMed ID: 8890349
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Statistical Approaches to Assess Biosimilarity from Analytical Data.
    Burdick R; Coffey T; Gutka H; Gratzl G; Conlon HD; Huang CT; Boyne M; Kuehne H
    AAPS J; 2017 Jan; 19(1):4-14. PubMed ID: 27709452
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Sowing confusion in the field: the interchangeable use of biosimilar terminology.
    McKinley L; Kelton JM; Popovian R
    Curr Med Res Opin; 2019 Apr; 35(4):619-621. PubMed ID: 30556742
    [TBL] [Abstract][Full Text] [Related]  

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

  • 36. 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; 66(93):24390-1. PubMed ID: 12356096
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Design and Analysis of Biosimilar Switching Studies.
    Chow SC; Lee SJ
    Pharmaceut Med; 2019 Oct; 33(5):379-388. PubMed ID: 31933227
    [TBL] [Abstract][Full Text] [Related]  

  • 38. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.
    Yang H; Novick S; Burdick RK
    PDA J Pharm Sci Technol; 2016 11/12; 70(6):547-559. PubMed ID: 27325594
    [TBL] [Abstract][Full Text] [Related]  

  • 39. 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; 65(242):78493-4. PubMed ID: 12362934
    [TBL] [Abstract][Full Text] [Related]  

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

    [Previous]   [Next]    [New Search]
    of 14.