BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

133 related articles for article (PubMed ID: 25356663)

  • 1. Testing assay linearity over a pre-specified range.
    Yang H; Novick SJ; LeBlond D
    J Biopharm Stat; 2015; 25(2):339-50. PubMed ID: 25356663
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Using tolerance intervals for assessment of pharmaceutical quality.
    Dong X; Tsong Y; Shen M; Zhong J
    J Biopharm Stat; 2015; 25(2):317-27. PubMed ID: 25356617
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Analytical procedure validation and the quality by design paradigm.
    Rozet E; Lebrun P; Michiels JF; Sondag P; Scherder T; Boulanger B
    J Biopharm Stat; 2015; 25(2):260-8. PubMed ID: 25357001
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Statistical considerations in setting product specifications.
    Dong X; Tsong Y; Shen M
    J Biopharm Stat; 2015; 25(2):280-94. PubMed ID: 25358110
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Guest editors' note: special issue on recent developments in statistical approaches for chemistry and manufacturing control (CMC) and quality-by-design(QbD).
    Tsong Y; Yang H
    J Biopharm Stat; 2015; 25(2):233. PubMed ID: 25437635
    [No Abstract]   [Full Text] [Related]  

  • 6. Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay.
    Shen M; Dong X; Tsong Y
    J Biopharm Stat; 2015; 25(2):269-79. PubMed ID: 25356783
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Quality assurance test of delivered dose uniformity of multiple-dose inhaler and dry powder inhaler drug products.
    Tsong Y; Dong X; Shen M; Lostritto RT
    J Biopharm Stat; 2015; 25(2):328-38. PubMed ID: 25357132
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Dissolution curve comparisons through the F(2) parameter, a Bayesian extension of the f(2) statistic.
    Novick S; Shen Y; Yang H; Peterson J; LeBlond D; Altan S
    J Biopharm Stat; 2015; 25(2):351-71. PubMed ID: 25357203
    [TBL] [Abstract][Full Text] [Related]  

  • 9. One- and two-stage Arrhenius models for pharmaceutical shelf life prediction.
    Fan Z; Zhang L
    J Biopharm Stat; 2015; 25(2):307-16. PubMed ID: 25358076
    [TBL] [Abstract][Full Text] [Related]  

  • 10. A quality by design approach for longitudinal quality attributes.
    Lebrun P; Giacoletti K; Scherder T; Rozet E; Boulanger B
    J Biopharm Stat; 2015; 25(2):247-59. PubMed ID: 25360720
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Non-normal random effects models for immunogenicity assay cut point determination.
    Zhang J; Yu B; Zhang L; Roskos L; Richman L; Yang H
    J Biopharm Stat; 2015; 25(2):295-306. PubMed ID: 25356500
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A statistical approach to determining criticality of residual host cell DNA.
    Yang H; Wei Z; Schenerman M
    J Biopharm Stat; 2015; 25(2):234-46. PubMed ID: 25358029
    [TBL] [Abstract][Full Text] [Related]  

  • 13. A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.
    Yang H; Zhang J
    PDA J Pharm Sci Technol; 2015; 69(6):725-35. PubMed ID: 26659103
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Estimation of the probability of passing the USP dissolution test.
    Wang H
    J Biopharm Stat; 2007; 17(3):407-13. PubMed ID: 17479390
    [TBL] [Abstract][Full Text] [Related]  

  • 15. On statistical evaluation of the linearity in assay validation.
    Hsieh E; Liu JP
    J Biopharm Stat; 2008; 18(4):677-90. PubMed ID: 18607801
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Flexibility and applicability of β-expectation tolerance interval approach to assess the fitness of purpose of pharmaceutical analytical methods.
    Bouabidi A; Talbi M; Bourichi H; Bouklouze A; El Karbane M; Boulanger B; Brik Y; Hubert P; Rozet E
    Drug Test Anal; 2012 Dec; 4(12):1014-27. PubMed ID: 22615163
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Assessing parallelism prior to determining relative potency.
    Hauck WW; Capen RC; Callahan JD; De Muth JE; Hsu H; Lansky D; Sajjadi NC; Seaver SS; Singer RR; Weisman D
    PDA J Pharm Sci Technol; 2005; 59(2):127-37. PubMed ID: 15971545
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence.
    Christopher D; Adams W; Amann A; Bertha C; Byron PR; Doub W; Dunbar C; Hauck W; Lyapustina S; Mitchell J; Morgan B; Nichols S; Pan Z; Singh GJ; Tougas T; Tsong Y; Wolff R; Wyka B
    AAPS PharmSciTech; 2007 Nov; 8(4):E90. PubMed ID: 18181550
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.
    Schepers U; El Deeb S; Ermer J; Wätzig H
    J Pharm Biomed Anal; 2007 Jan; 43(2):708-10. PubMed ID: 16904281
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products.
    Montes RO; Burdick RK; Leblond DJ
    PDA J Pharm Sci Technol; 2019; 73(1):39-59. PubMed ID: 30361286
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.