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.
134 related articles for article (PubMed ID: 37580127)
1. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results. Mercea PV; Ossberger M; Wyrwich R; Herburger M; Barge V; Aluri R; Toşa V PDA J Pharm Sci Technol; 2024 Feb; 78(1):3-32. PubMed ID: 37580127 [TBL] [Abstract][Full Text] [Related]
2. Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations. Mercea PV; Ossberger M; Wyrwich R; Herburger M; Barge V; Aluri R; Toşa V PDA J Pharm Sci Technol; 2024 Feb; 78(1):33-44. PubMed ID: 37580130 [TBL] [Abstract][Full Text] [Related]
3. 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]
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. 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]
6. 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]
7. Application of Arrhenius Kinetics to Acceleration of Controlled Extraction Studies. Jenke D PDA J Pharm Sci Technol; 2019; 73(2):135-169. PubMed ID: 30361282 [TBL] [Abstract][Full Text] [Related]
8. Identification of an Adduct Impurity of an Active Pharmaceutical Ingredient and a Leachable in an Ophthalmic Drug Product Using LC-QTOF. Gollapalli R; Singh G; Blinder A; Brittin J; Sengupta A; Mondal B; Patel M; Pati B; Lee J; Ghode A; Kote M J Pharm Sci; 2019 Oct; 108(10):3187-3193. PubMed ID: 31226425 [TBL] [Abstract][Full Text] [Related]
9. The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers. Jenke D; Odufu A; Poss M Eur J Pharm Sci; 2006 Feb; 27(2-3):133-42. PubMed ID: 16246534 [TBL] [Abstract][Full Text] [Related]
10. 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]
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. Linear solvation energy relationships (LSERs) for robust prediction of partition coefficients between low density polyethylene and water. Part I: Experimental partition coefficients and model calibration. Egert T; Langowski HC Eur J Pharm Sci; 2022 May; 172():106137. PubMed ID: 35150822 [TBL] [Abstract][Full Text] [Related]
13. 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]
14. 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]
15. 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]
16. Identification of leachable impurities in an ophthalmic drug product originating from a polymer additive Irganox 1010 using mass spectroscopy. Singh G; Gollapalli R; Blinder A; Patel M J Pharm Biomed Anal; 2018 Apr; 152():197-203. PubMed ID: 29414013 [TBL] [Abstract][Full Text] [Related]
17. 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]
18. 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]
19. 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]
20. 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] [Next] [New Search]