BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

365 related articles for article (PubMed ID: 17701994)

  • 1. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables.
    Jenke D
    J Pharm Sci; 2007 Oct; 96(10):2566-81. PubMed ID: 17701994
    [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. Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations.
    Norwood DL; Paskiet D; Ruberto M; Feinberg T; Schroeder A; Poochikian G; Wang Q; Deng TJ; DeGrazio F; Munos MK; Nagao LM
    Pharm Res; 2008 Apr; 25(4):727-39. PubMed ID: 18183477
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions.
    Jenke DR; Rabinow BE
    PDA J Pharm Sci Technol; 2017; 71(3):225-233. PubMed ID: 28196915
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Use of thermal desorption GC-MS to characterize packaging materials for potential extractables.
    Zweiben C; Shaw AJ
    PDA J Pharm Sci Technol; 2009; 63(4):353-9. PubMed ID: 20088248
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches.
    Cuadros-Rodríguez L; Lazúen-Muros M; Ruiz-Samblás C; Navas-Iglesias N
    Int J Pharm; 2020 Jun; 583():119332. PubMed ID: 32360549
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
    Allison G; Cain YT; Cooney C; Garcia T; Bizjak TG; Holte O; Jagota N; Komas B; Korakianiti E; Kourti D; Madurawe R; Morefield E; Montgomery F; Nasr M; Randolph W; Robert JL; Rudd D; Zezza D
    J Pharm Sci; 2015 Mar; 104(3):803-12. PubMed ID: 25830179
    [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. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices.
    Jenke D
    PDA J Pharm Sci Technol; 2002; 56(6):332-71. PubMed ID: 12497770
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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]  

  • 13. An extractables/leachables strategy facilitated by collaboration between drug product vendors and plastic material/system suppliers.
    Jenke D
    PDA J Pharm Sci Technol; 2007; 61(1):17-23. PubMed ID: 17390700
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Extractables and leachables considerations for prefilled syringes.
    Jenke DR
    Expert Opin Drug Deliv; 2014 Oct; 11(10):1591-600. PubMed ID: 24955780
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Linking extractables and leachables in container/closure applications.
    Jenke DR
    PDA J Pharm Sci Technol; 2005; 59(4):265-81. PubMed ID: 16218205
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.
    Jenke D
    PDA J Pharm Sci Technol; 2015; 69(6):677-712. PubMed ID: 26659101
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Extractable substances from plastic materials used in solution contact applications: an updated review.
    Jenke D
    PDA J Pharm Sci Technol; 2006; 60(3):191-207. PubMed ID: 17089688
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Modeling of the solution interaction properties of plastic materials used in pharmaceutical product container systems.
    Jenke D; Couch T; Gillum A; Sadain S
    PDA J Pharm Sci Technol; 2009; 63(4):294-306. PubMed ID: 20088244
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation.
    Chillon A; Zuccato D
    PDA J Pharm Sci Technol; 2019; 73(3):235-246. PubMed ID: 30651335
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 19.