243 related articles for article (PubMed ID: 31843988)
1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review.
Jenke D
PDA J Pharm Sci Technol; 2020; 74(3):324-347. PubMed ID: 31843988
[TBL] [Abstract][Full Text] [Related]
2. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review.
Jenke DR; Stults CL; Paskiet DM; Ball DJ; Nagao LM
PDA J Pharm Sci Technol; 2015 1/2; 69(1):1-48. PubMed ID: 25691713
[TBL] [Abstract][Full Text] [Related]
3. How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products.
Jenke D
PDA J Pharm Sci Technol; 2019; 73(2):181-190. PubMed ID: 30232139
[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. 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]
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. 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]
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. 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]
11. 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]
12. A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products.
Jenke D
PDA J Pharm Sci Technol; 2021; 75(6):506-535. PubMed ID: 33990423
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete.
Jenke D; Couch TR; Robinson SJ; Volz TJ; Colton RH
PDA J Pharm Sci Technol; 2014; 68(3):256-70. PubMed ID: 25188347
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. 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]
17. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3-Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices.
Jenke D
PDA J Pharm Sci Technol; 2020; 74(1):134-146. PubMed ID: 31209166
[TBL] [Abstract][Full Text] [Related]
18. A Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins.
Luo Y; Sekhar C; Lee H; Fujimori K; Ronk M; Semin D; Nashed-Samuel Y
J Pharm Sci; 2020 Nov; 109(11):3378-3385. PubMed ID: 32745562
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. 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]
[Next] [New Search]