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Items: 1 to 20 of 104

1.

PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, Nov. 3-4, 2011, Rockville, MD.

Khan AS, Lubiniecki A, King KE.

PDA J Pharm Sci Technol. 2012 Nov-Dec;66(6):502-11. doi: 10.5731/pdajpst.2012.00895.

PMID:
23183646
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.

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
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.

Detection of adventitious viruses from biologicals using a broad-spectrum microbial detection array.

Jaing C, Gardner S, McLoughlin K, Thissen JB, Slezak T.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):668-74. doi: 10.5731/pdajpst.2011.00838.

PMID:
22294595
6.

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
7.

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
8.

Detection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero Cells.

Ma H, Khan AS.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):685-9. doi: 10.5731/pdajpst.2011.00843.

PMID:
22294598
9.

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
10.

Detection of adventitious viruses in biologicals--a rare occurrence.

Nims RW.

Dev Biol (Basel). 2006;123:153-64; discussion 183-97.

PMID:
16566443
11.

New technologies and challenges of novel virus detection.

Khan AS, Ma H, Taliaferro LP, Galvin TA, Shaheduzzaman S.

PDA J Pharm Sci Technol. 2014 Nov-Dec;68(6):661-6. doi: 10.5731/pdajpst.2014.01029.

PMID:
25475641
12.

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
13.

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
14.

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
15.

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
16.

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
17.

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
18.

Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.

Gombold J, Karakasidis S, Niksa P, Podczasy J, Neumann K, Richardson J, Sane N, Johnson-Leva R, Randolph V, Sadoff J, Minor P, Schmidt A, Duncan P, Sheets RL.

Vaccine. 2014 May 19;32(24):2916-26. doi: 10.1016/j.vaccine.2014.02.021. Epub 2014 Mar 25.

19.

Plaque purification as a method to mitigate the risk of adventitious-agent contamination in influenza vaccine virus seeds.

Murata H, Macauley J, Lewis AM Jr, Peden K.

Vaccine. 2011 Apr 12;29(17):3155-61. doi: 10.1016/j.vaccine.2011.02.041. Epub 2011 Feb 26.

PMID:
21354480
20.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138

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