Similar articles for PMID: 30232141

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1

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. Johns J, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):640-650. doi: 10.5731/pdajpst.2018.009027. Epub 2018 Sep 19. PDA J Pharm Sci Technol. 2018. PMID: 30232141

2

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. Anger S, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):635-647. doi: 10.5731/pdajpst.2019.010645. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2019. PMID: 31420504

3

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

Mathonet S, Mahler HC, Esswein ST, Mazaheri M, Cash PW, Wuchner K, Kallmeyer G, Das TK, Finkler C, Lennard A. Mathonet S, et al. PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):392-408. doi: 10.5731/pdajpst.2015.006189. Epub 2016 Apr 18. PDA J Pharm Sci Technol. 2016. PMID: 27091885 Review.

4

Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations.

Ayres JD. Ayres JD. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):626-639. doi: 10.5731/pdajpst.2018.008615. Epub 2018 Aug 29. PDA J Pharm Sci Technol. 2018. PMID: 30158238

5

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. Brown H, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):147-162. doi: 10.5731/pdajpst.2016.006999. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789803

6

Assessment of Extractable Elements from Elastomers.

Paskiet D, Kraft C, Tullo E, Hunter J, Zurbriggen D. Paskiet D, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):83-91. doi: 10.5731/pdajpst.2017.008193. Epub 2018 Jul 20. PDA J Pharm Sci Technol. 2019. PMID: 30030347

7

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. Oni Y, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):572-587. doi: 10.5731/pdajpst.2018.009670. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101708

8

Analysis of Particulate Matter in Liquid-Finished Dosage Forms.

Duchek J, Havasi B. Duchek J, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):608-625. doi: 10.5731/pdajpst.2017.008292. Epub 2018 May 31. PDA J Pharm Sci Technol. 2018. PMID: 29853612 Review.

9

The scientific basis for visible particle inspection.

Knapp JZ. Knapp JZ. PDA J Pharm Sci Technol. 1999 Nov-Dec;53(6):291-302. PDA J Pharm Sci Technol. 1999. PMID: 10754727

10

Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach.

Langille SE. Langille SE. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):359-366. doi: 10.5731/pdajpst.2019.010462. Epub 2019 Nov 15. PDA J Pharm Sci Technol. 2020. PMID: 31732691

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