A Bayesian Approach to Residual Host Cell DNA Safety Assessment

Harry Yang; Jianchun Zhang

doi:10.5731/pdajpst.2015.006296

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A Bayesian Approach to Residual Host Cell DNA Safety Assessment

Harry Yang and Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology January 2016, pdajpst.2015.006296; DOI: https://doi.org/10.5731/pdajpst.2015.006296

Harry Yang

1 MedImmune;

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For correspondence: yangh@medimmune.com

Jianchun Zhang

2 MedImmune.com

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For correspondence: zhangji@medimmune.com

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pdajpst.2015.006296

DOI

https://doi.org/10.5731/pdajpst.2015.006296

PubMed

26797975

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received November 3, 2015
Accepted January 5, 2016
Published online January 21, 2016.

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Author Information

Harry Yang1,3 (yangh{at}medimmune.com) and
Jianchun Zhang2 (zhangji{at}medimmune.com)

¹ MedImmune;
² MedImmune.com

↵* Corresponding author; email: yangh{at}medimmune.com

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A Bayesian Approach to Residual Host Cell DNA Safety Assessment

Harry Yang, Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology Jan 2016, pdajpst.2015.006296; DOI: 10.5731/pdajpst.2015.006296

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A Bayesian Approach to Residual Host Cell DNA Safety Assessment

Harry Yang, Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology Jan 2016, pdajpst.2015.006296; DOI: 10.5731/pdajpst.2015.006296

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Keywords

Acceptable limits
Bayesian analysis
Infectivity
Oncogenicity
Residual DNA
Risk-based assessment.

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