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 *

182 related articles for article (PubMed ID: 34324943)

  • 1. A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
    Qi L; Liu J; Ronk M; Gallegos A; Fujimori K; Luo Y; Li K; Lee H; Nashed-Samuel Y
    J Pharm Sci; 2021 Nov; 110(11):3580-3593. PubMed ID: 34324943
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
    Gallegos A; Liu J; Ronk M; Qi L; Li K; Semin D; Nashed-Samuel Y
    J Pharm Sci; 2022 Jun; 111(6):1599-1604. PubMed ID: 35257694
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products.
    Ronk M; Liu J; Gallegos A; Luo Y; Fujimori K; Li K; Lee H; Nashed-Samuel Y
    PDA J Pharm Sci Technol; 2020; 74(6):627-643. PubMed ID: 32675308
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper.
    Kiminami H; Takeuchi K; Nakamura K; Abe Y; Lauwers P; Dierick W; Yoshino K; Suzuki S
    PDA J Pharm Sci Technol; 2015; 69(6):713-24. PubMed ID: 26659102
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry.
    Breckenridge L; Oni Y; Evans C; Franck J; Wood S; Xu M; Sahin E; Zacour B
    PDA J Pharm Sci Technol; 2023; 77(3):197-210. PubMed ID: 36241213
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Observation and Mitigation of Leachables from Non-Product Contact Materials in Electromechanical Delivery Devices for Biotechnology Products.
    Liu J; Ronk M; Luo Y; Wypych J; Zhang Z; Perez-Pacheco J; Jin E; Shah B; Richardson J; Li K; Semin D; Nashed-Samuel Y
    J Pharm Sci; 2021 Dec; 110(12):3794-3802. PubMed ID: 34390741
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).
    Paskiet D; Jenke D; Ball D; Houston C; Norwood DL; Markovic I
    PDA J Pharm Sci Technol; 2013; 67(5):430-47. PubMed ID: 24084659
    [TBL] [Abstract][Full Text] [Related]  

  • 10. On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals.
    Wakankar AA; Wang YJ; Canova-Davis E; Ma S; Schmalzing D; Grieco J; Milby T; Reynolds T; Mazzarella K; Hoff E; Gomez S; Martin-Moe S
    J Pharm Sci; 2010 May; 99(5):2209-18. PubMed ID: 20039383
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. 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]  

  • 13. Assessment of Extractable Elements from Elastomers.
    Paskiet D; Kraft C; Tullo E; Hunter J; Zurbriggen D
    PDA J Pharm Sci Technol; 2019; 73(1):83-91. PubMed ID: 30030347
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. A Case Study Demonstrating the Importance of Glass Vial Selection for Parenteral Pharmaceutical Products.
    Sperry A; Imhoff D; Traunfeld J; Gundagari S; Smaga K; Singh G
    J Pharm Sci; 2024 Sep; 113(9):2974-2980. PubMed ID: 38880302
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.
    Zuleger B; Werner U; Kort A; Glowienka R; Wehnes E; Duncan D
    PDA J Pharm Sci Technol; 2012; 66(5):453-65. PubMed ID: 23035029
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products.
    Zdravkovic SA
    Pharm Res; 2020 Mar; 37(4):76. PubMed ID: 32232571
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume.
    Hladik B; Buscke F; Frost R; Rothhaar U
    PDA J Pharm Sci Technol; 2019; 73(4):345-355. PubMed ID: 30770482
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Perspectives on the PQRI Extractables and Leachables "Safety Thresholds and Best Practices" Recommendations for Inhalation Drug Products.
    Norwood DL; Nagao LM; Stults CL
    PDA J Pharm Sci Technol; 2013; 67(5):413-29. PubMed ID: 24084658
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.