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 *

142 related articles for article (PubMed ID: 21057904)

  • 1. Reducing the risk of contamination of sterile parenteral products via ready-to-use closure components.
    Curry W; Conway S; Goodfield C; Miller K; Mueller RL; Polini E
    AAPS PharmSciTech; 2010 Dec; 11(4):1572-9. PubMed ID: 21057904
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.
    Oni Y; Song X; Schrader M; Kulshrestha A; Franck J; Asselta R; Flores-Crespo C; Mantri RV
    PDA J Pharm Sci Technol; 2019; 73(6):572-587. PubMed ID: 31101708
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.
    Brown H; Mahler HC; Mellman J; Nieto A; Wagner D; Schaar M; Mathaes R; Kossinna J; Schmitting F; Dreher S; Roehl H; Hemminger M; Wuchner K
    PDA J Pharm Sci Technol; 2017; 71(2):147-162. PubMed ID: 27789803
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.
    Jenke D; Egert T; Hendricker A; Castner J; Feinberg T; Houston C; Hunt DG; Lynch M; Nicholas K; Norwood DL; Paskiet D; Ruberto M; Smith EJ; Holcomb F; Markovic I
    PDA J Pharm Sci Technol; 2017; 71(2):68-87. PubMed ID: 27974627
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.
    Simonetti A; Amari F
    PDA J Pharm Sci Technol; 2015; 69(1):108-22. PubMed ID: 25691719
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity.
    Ovadia R; Streubel A; Webb-Vargas Y; Ulland L; Luemkemann J; Rauch K; Eder J; Lam P; Tegoulia V; Maa YF
    PDA J Pharm Sci Technol; 2019; 73(1):2-15. PubMed ID: 29954924
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Development of a dye ingress method to assess container-closure integrity: correlation to microbial ingress.
    Burrell LS; Carver MW; DeMuth GE; Lambert WJ
    PDA J Pharm Sci Technol; 2000; 54(6):449-55. PubMed ID: 11107837
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.
    Hasanain F; Guenther K; Mullett WM; Craven E
    PDA J Pharm Sci Technol; 2014; 68(2):113-37. PubMed ID: 24668600
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The influence of clean room design on product contamination.
    Whyte W
    J Parenter Sci Technol; 1984; 38(3):103-8. PubMed ID: 6747777
    [No Abstract]   [Full Text] [Related]  

  • 11. Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity.
    Degrazio FL
    PDA J Pharm Sci Technol; 2018; 72(1):15-34. PubMed ID: 29030527
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.
    Santos AMC; Doria MS; Meirinhos-Soares L; Almeida AJ; Menezes JC
    PDA J Pharm Sci Technol; 2018; 72(1):62-72. PubMed ID: 29242394
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies.
    Peláez SS; Mahler HC; Herdlitschka C; Wertli T; Kahl M; Koulov A; Matter A; Singh SK; Widmer M; Germershaus O; Mathaes R
    PDA J Pharm Sci Technol; 2019; 73(3):220-234. PubMed ID: 30651337
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Achieving "Zero" Defects for Visible Particles in Injectables.
    Johns J; Golfetto P; Bush T; Fantozzi G; Shabushnig J; Perry A; Degrazio F; Streich D; Miller J; Soukiassian H; Stanton A; Watson R
    PDA J Pharm Sci Technol; 2018; 72(6):640-650. PubMed ID: 30232141
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.
    Fed Regist; 1998 Jan; 63(18):4272-3. PubMed ID: 10177326
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Quantitative and mechanistic measurements of container/closure integrity. Bubble, liquid, and microbial leakage tests.
    Morton DK; Lordi NG; Troutman LH; Ambrosio TJ
    J Parenter Sci Technol; 1989; 43(3):104-8. PubMed ID: 2732847
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Microbial barrier assessment of Tyvek stopper packaging for rubber closures.
    Moldenhauer JE; Bass SA; Kupinski MJ; Walters ML; Rubio SL
    PDA J Pharm Sci Technol; 1996; 50(6):391-8. PubMed ID: 9038086
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Mass extraction container closure integrity physical testing method development for parenteral container closure systems.
    Yoon SY; Sagi H; Goldhammer C; Li L
    PDA J Pharm Sci Technol; 2012; 66(5):403-19. PubMed ID: 23035025
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.
    Victor KG; Levac L; Timmins M; Veale J
    PDA J Pharm Sci Technol; 2017; 71(6):429-453. PubMed ID: 28733333
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations.
    Anger S; Begat C; Crnko V; Fantozzi G; Farach W; Fitzpatrick S; Gallagher B; Huelsmann S; Kinsey P; Langlade V; Lefevre G; Legendre E; McLean K; Miller J; Patel R; Perry A; Soukiassian H; Stanton A; Streich D; Timmons C; Vaneylen D; van Hoose T; Wildling L; Windover M
    PDA J Pharm Sci Technol; 2019; 73(6):635-647. PubMed ID: 31420504
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.