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 *

209 related articles for article (PubMed ID: 23786363)

  • 1. Evaluating the performance of the ICH guidelines for shelf life estimation.
    Quinlan M; Stroup W; Schwenke J; Christopher D
    J Biopharm Stat; 2013; 23(4):881-96. PubMed ID: 23786363
    [TBL] [Abstract][Full Text] [Related]  

  • 2. On the distribution of batch shelf lives.
    Quinlan M; Stroup W; Christopher D; Schwenke J
    J Biopharm Stat; 2013; 23(4):897-920. PubMed ID: 23786624
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Stability analysis with discrete responses.
    Chow SC; Shao J
    J Biopharm Stat; 2003 Aug; 13(3):451-62. PubMed ID: 12921393
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Evaluating Current Practices in Shelf Life Estimation.
    Capen R; Christopher D; Forenzo P; Huynh-Ba K; LeBlond D; Liu O; O'Neill J; Patterson N; Quinlan M; Rajagopalan R; Schwenke J; Stroup W
    AAPS PharmSciTech; 2018 Feb; 19(2):668-680. PubMed ID: 28948584
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Two-phase shelf-life estimation.
    Shao J; Chow SC
    Stat Med; 2001 Apr; 20(8):1239-48. PubMed ID: 11304739
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Combined statistical analyses for long-term stability data with multiple storage conditions: a simulation study.
    Almalik O; Nijhuis MB; van den Heuvel ER
    J Biopharm Stat; 2014; 24(3):493-506. PubMed ID: 24697656
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Industry perspectives on ICH guidelines.
    Rockhold FW
    Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Overview of stability study designs.
    Lin TY; Chen CW
    J Biopharm Stat; 2003 Aug; 13(3):337-54. PubMed ID: 12921386
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Estimation of the shelf-life of drugs with mixed effects models.
    Chen JJ; Hwang JS; Tsong Y
    J Biopharm Stat; 1995 Mar; 5(1):131-40. PubMed ID: 7613558
    [TBL] [Abstract][Full Text] [Related]  

  • 10. International Conference on Harmonisation; evaluation of stability data; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2004 Jun; 69(110):32010-1. PubMed ID: 15185712
    [TBL] [Abstract][Full Text] [Related]  

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

  • 12. Shelf life determination based on equivalence assessment.
    Tsong Y; Chen WJ; Lin TY; Chen CW
    J Biopharm Stat; 2003 Aug; 13(3):431-49. PubMed ID: 12921392
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Stability testing requirements for vaccines--draft guidelines of the International Conference on Harmonization.
    Haase M
    Dev Biol Stand; 1996; 87():309-18. PubMed ID: 8854031
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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; 77(97):29665-6. PubMed ID: 22616137
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Equivalence tests for shelf life and average drug content in stability studies.
    Djira GD; Hothorn LA; Tsong Y
    J Biopharm Stat; 2008; 18(5):985-95. PubMed ID: 18781530
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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; 77(110):33748-9. PubMed ID: 22675782
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [Objectives and organization of the International Conference on Harmonization].
    Juillet Y
    Ann Pharm Fr; 1999 Mar; 57(2):137-42. PubMed ID: 10365469
    [TBL] [Abstract][Full Text] [Related]  

  • 18. On the shelf life of pharmaceutical products.
    Capen R; Christopher D; Forenzo P; Ireland C; Liu O; Lyapustina S; O'Neill J; Patterson N; Quinlan M; Sandell D; Schwenke J; Stroup W; Tougas T
    AAPS PharmSciTech; 2012 Sep; 13(3):911-8. PubMed ID: 22729779
    [TBL] [Abstract][Full Text] [Related]  

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

  • 20. 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]  

    [Next]    [New Search]
    of 11.