A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation

Steven Novick; Perceval Sondag; Tim Schofield; Kenneth Miller

doi:10.5731/pdajpst.2017.008094

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A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation

Steven Novick, Perceval Sondag, Tim Schofield and Kenneth Miller

PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: https://doi.org/10.5731/pdajpst.2017.008094

Steven Novick

1MedImmune LLC, Gaithersburg, MD;

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For correspondence: novicks@medimmune.com

Perceval Sondag

2Arlenda Inc., Berwyn, PA; and

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Tim Schofield

3GlaxoSmithKline PLC, Rockville, MD

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Kenneth Miller

1MedImmune LLC, Gaithersburg, MD;

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vol. 72 no. 3 249-263

DOI

https://doi.org/10.5731/pdajpst.2017.008094

PubMed

29444993

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 18, 2018.

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previous version (February 14, 2018 - 18:16).
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Author Information

Steven Novick1,*,
Perceval Sondag2,
Tim Schofield3 and
Kenneth Miller1

¹MedImmune LLC, Gaithersburg, MD;
²Arlenda Inc., Berwyn, PA; and
³GlaxoSmithKline PLC, Rockville, MD

↵* Corresponding Author: One MedImmune Way, Gaithersburg, MD 20878. E-mail novicks{at}medimmune.com

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A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation

Steven Novick, Perceval Sondag, Tim Schofield, Kenneth Miller

PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: 10.5731/pdajpst.2017.008094

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A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation

Steven Novick, Perceval Sondag, Tim Schofield, Kenneth Miller

PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 249-263; DOI: 10.5731/pdajpst.2017.008094

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