BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

195 related articles for article (PubMed ID: 25336417)

  • 1. Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications.
    Pahl I; Dorey S; Barbaroux M; Lagrange B; Frankl H
    PDA J Pharm Sci Technol; 2014; 68(5):456-71. PubMed ID: 25336417
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.
    Li K; Rogers G; Nashed-Samuel Y; Lee H; Mire-Sluis A; Cherney B; Forster R; Yeh P; Markovic I
    PDA J Pharm Sci Technol; 2015; 69(5):590-619. PubMed ID: 26429108
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems.
    Jenke D; Carlson T
    PDA J Pharm Sci Technol; 2014; 68(5):407-55. PubMed ID: 25336416
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study.
    Zdravkovic SA; Bruss MD; Piccoli RF; Wood DM
    PDA J Pharm Sci Technol; 2014; 68(5):504-26. PubMed ID: 25336421
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
    Menzel R; Pahl I; Loewe T; Hauk A
    PDA J Pharm Sci Technol; 2018; 72(3):298-316. PubMed ID: 29343620
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Extractables analysis of single-use flexible plastic biocontainers.
    Marghitoiu L; Liu J; Lee H; Perez L; Fujimori K; Ronk M; Hammond MR; Nunn H; Lower A; Rogers G; Nashed-Samuel Y
    PDA J Pharm Sci Technol; 2015; 69(1):49-58. PubMed ID: 25691714
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Qualitative assessment of extractables from single-use components and the impact of reference standard selection.
    Jordi MA; Khera S; Roland K; Jiang L; Solomon P; Nelson J; Lateef SS; Woods J; Martin L; Martin S; Aiello F; Chen N
    J Pharm Biomed Anal; 2018 Feb; 150():368-376. PubMed ID: 29287264
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Large-Scale Assessment of Extractables and Leachables in Single-Use Bags for Biomanufacturing.
    Dorival-García N; Carillo S; Ta C; Roberts D; Comstock K; Lofthouse S; Ciceri E; D'Silva K; Kierans G; Kaisermayer C; Lindeberg A; Bones J
    Anal Chem; 2018 Aug; 90(15):9006-9015. PubMed ID: 29943976
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Using Extractables Data of Sterile Filter Components for Scaling Calculations.
    Pahl I; Menzel R; Hauk A; Loewe T
    PDA J Pharm Sci Technol; 2019; 73(6):523-537. PubMed ID: 31101707
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors.
    Jordi MA; Rowland K; Liu W; Cao X; Zong J; Ren Y; Liang Z; Zhou X; Louis M; Lerner K
    J Pharm Biomed Anal; 2020 Jul; 186():113334. PubMed ID: 32387747
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Equivalence study of extractables from single-use biopharmaceutical manufacturing equipment after X-ray or gamma irradiation.
    Menzel R; Pahl I; Dorey S; Maier T; Hauk A
    Int J Pharm; 2023 Mar; 634():122677. PubMed ID: 36740079
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards.
    Jenke D
    PDA J Pharm Sci Technol; 2017; 71(5):346-367. PubMed ID: 28512176
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products.
    Jenke D; Castner J; Egert T; Feinberg T; Hendricker A; Houston C; Hunt DG; Lynch M; Shaw A; Nicholas K; Norwood DL; Paskiet D; Ruberto M; Smith EJ; Holcomb F
    PDA J Pharm Sci Technol; 2013; 67(5):448-511. PubMed ID: 24084660
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes.
    Jenke D
    PDA J Pharm Sci Technol; 2023; 77(4):329-338. PubMed ID: 37001885
    [TBL] [Abstract][Full Text] [Related]  

  • 15. The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete.
    Jenke D; Couch TR; Robinson SJ; Volz TJ; Colton RH
    PDA J Pharm Sci Technol; 2014; 68(3):256-70. PubMed ID: 25188347
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Extractables/leachables from plastic tubing used in product manufacturing.
    Jenke DR; Story J; Lalani R
    Int J Pharm; 2006 Jun; 315(1-2):75-92. PubMed ID: 16563675
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Risk-based scientific approach for determination of extractables/leachables from biomanufacturing of antibody-drug conjugates (ADCs).
    Ding W
    Methods Mol Biol; 2013; 1045():303-11. PubMed ID: 23913157
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Non-volatile extractable analysis of prefilled syringes for parenteral administration of drug products.
    Dorival-García N; Larsson I; Bones J
    J Pharm Biomed Anal; 2017 Aug; 142():337-342. PubMed ID: 28538204
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction.
    Norwood DL; Mullis JO; Davis M; Pennino S; Egert T; Gonnella NC
    PDA J Pharm Sci Technol; 2013; 67(3):267-87. PubMed ID: 23752753
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug.
    Wei Y; Wu Y; Zhu T; Li Z; Zhang Y
    J Pharm Biomed Anal; 2017 May; 138():256-266. PubMed ID: 28231528
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.