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Items: 1 to 20 of 102

1.

Application of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus Vaccines.

Pennathur S.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):730-6. doi: 10.5731/pdajpst.2011.00851.

PMID:
22294607
2.

Current testing methods and challenges for detection of adventitious viruses.

Khan AS.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):627-33. doi: 10.5731/pdajpst.2011.00831.

PMID:
22294589
3.

Regulatory approaches for control of viral contamination of vaccines.

McClenahan S, Uhlenhaut C, Krause PR.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):557-62. doi: 10.5731/pdajpst.2011.00819.

PMID:
22294577
4.

Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections.

Eltermann J.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):694-7. doi: 10.5731/pdajpst.2011.00845.

PMID:
22294603
5.

Evolution of approaches to viral safety issues for biological products.

Lubiniecki AS.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):547-56. doi: 10.5731/pdajpst.2011.00818.

PMID:
22294576
6.

FDA post-approval expectations for adventitious virus contamination prevention.

Friedman RL.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):698-712. doi: 10.5731/pdajpst.2011.00846.

PMID:
22294604
7.

Theory and practice of conventional adventitious virus testing.

Gregersen JP.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):634-44. doi: 10.5731/pdajpst.2011.00832.

PMID:
22294590
8.

Case study of apparent virus contamination in biopharmaceutical product at centocor.

Hendricks LC, Vacante DA.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):612-3. doi: 10.5731/pdajpst.2011.00825.

PMID:
22294583
9.

Identification and remediation of a cell culture virus contamination.

Jones N.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):615. doi: 10.5731/pdajpst.2011.00822.

PMID:
22294585
10.

Practicing safe cell culture: applied process designs for minimizing virus contamination risk.

Kiss RD.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):715-29. doi: 10.5731/pdajpst.2011.00852.

PMID:
22294606
11.

Application of quality by design in the control of adventitious viruses: gaps in current processes in the prevention of virus contaminants.

Cherney B.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):754-66. doi: 10.5731/pdajpst.2011.00849.

PMID:
22294609
12.

Introduction to workshop: adventitious viruses in biologics--detection and mitigation strategies.

Khan AS, Hughes P, Wiebe M.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):544-6. doi: 10.5731/pdajpst.2011.00817.

PMID:
22294575
13.

Current European regulations for control of adventitious virus safety.

Bl├╝mel J.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):568-79. doi: 10.5731/pdajpst.2011.00821.

PMID:
22294579
14.

Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices.

Rosenberg AS, Cherney B, Brorson K, Clouse K, Kozlowski S, Hughes P, Friedman R.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):563-7. doi: 10.5731/pdajpst.2011.00820.

PMID:
22294578
15.

A biotech production facility contamination case study--minute mouse virus.

Skrine J.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):599-611. doi: 10.5731/pdajpst.2011.00823.

PMID:
22294582
16.

Overview of emerging technologies to detect adventitious agents.

Onions D.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):654-9. doi: 10.5731/pdajpst.2011.00834. Review.

PMID:
22294592
17.

Breakout Session A: Elimination or Treatment of High-risk Raw Materials.

Kiss R, Drews R.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):767-77. doi: 10.5731/pdajpst.2011.00850.

PMID:
22294610
18.

Broadening our expectations for viral safety risk mitigation.

Kljavin IJ.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):645-53. doi: 10.5731/pdajpst.2011.00833.

PMID:
22294591
19.

Viral Safety of Plasma-derived Products.

Farshid M.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):737-53. doi: 10.5731/pdajpst.2011.00848.

PMID:
22294608
20.

A microarray platform for virus detection and identification.

Munroe D.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):691. doi: 10.5731/pdajpst.2011.00839.

PMID:
22294600

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