BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

245 related articles for article (PubMed ID: 32387747)

  • 1. 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]  

  • 2. An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET).
    Jordi M; Heise T
    PDA J Pharm Sci Technol; 2021; 75(3):289-301. PubMed ID: 33199517
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation.
    Jenke D; Christiaens P; Beusen JM; Verlinde P; Baeten J
    PDA J Pharm Sci Technol; 2022; 76(3):178-199. PubMed ID: 34782443
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables.
    Jenke D
    PDA J Pharm Sci Technol; 2020; 74(3):348-358. PubMed ID: 32295860
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Identification and quantification of medical device extractables and leachables via non-target analysis (NTA); Analytical uncertainty.
    Jenke D; Christiaens P; Heise T
    J Pharm Biomed Anal; 2024 Apr; 241():115985. PubMed ID: 38301578
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. 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]  

  • 8. 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]  

  • 9. 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]  

  • 10. Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?
    Jenke D; Christiaens P; Verlinde P; Baeten J; Beusen JM
    PDA J Pharm Sci Technol; 2022; 76(3):236-247. PubMed ID: 34782445
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. 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]  

  • 13. The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation.
    Jenke D; Heise T
    PDA J Pharm Sci Technol; 2021; 75(3):273-288. PubMed ID: 33199516
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Establishment of a reference standard database for use in the qualitative and semi-quantitative analysis of pharmaceutical contact materials within an extractables survey by GC-MS.
    Zdravkovic SA; Duong CT; Hellenbrand AA; Duff SR; Dreger AL
    J Pharm Biomed Anal; 2018 Mar; 151():49-60. PubMed ID: 29306734
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Supercritical Fluid Extraction Combined with Ultrahigh Performance Liquid Chromatography Quadrupole Time-of-Flight Mass Spectrometry for Determination of Extractables to Evaluate Compatibility of Drugs with Rubber Closures.
    Sun X; Zheng X; Tang Y; Debrah AA; Du Z
    AAPS PharmSciTech; 2021 Jan; 22(1):50. PubMed ID: 33458791
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1-Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission.
    Christiaens P; Beusen JM; Verlinde P; Baeten J; Jenke D
    PDA J Pharm Sci Technol; 2020; 74(1):90-107. PubMed ID: 31209164
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals.
    Sica VP; Krivos KL; Kiehl DE; Pulliam CJ; Henry ID; Baker TR
    Mass Spectrom Rev; 2020 Mar; 39(1-2):212-226. PubMed ID: 30921495
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Identification and quantification of extractables and leachables in laminated film and pouches for pharmaceutical packaging.
    Fu C; Zhang X; Lei S; Zou M; Wang L; Jiao J; Yang Q
    J Pharm Biomed Anal; 2022 Oct; 220():115015. PubMed ID: 36054946
    [TBL] [Abstract][Full Text] [Related]  

  • 20. 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]  

    [Next]    [New Search]
    of 13.