Susan Kirshner

Susan Kirshner

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Susan Kirshner

Susan Kirshner

Publications by authors named "Susan Kirshner"

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A Model-Based Approach to Quantify the Time-Course of Anti-Drug Antibodies for Therapeutic Proteins.

Clin Pharmacol Ther 2019 Apr 9;105(4):970-978. Epub 2018 Dec 9.

Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://doi.wiley.com/10.1002/cpt.1267
Publisher Site
http://dx.doi.org/10.1002/cpt.1267DOI Listing
April 2019

Report on the AAPS Immunogenicity Guidance Forum.

AAPS J 2019 Apr 16;21(4):55. Epub 2019 Apr 16.

Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.

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http://link.springer.com/10.1208/s12248-019-0328-8
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http://dx.doi.org/10.1208/s12248-019-0328-8DOI Listing
April 2019

Mechanisms Underlying the Immunogenicity of Therapeutic Proteins: Risk Assessment and Management Strategies.

Authors:
Susan L Kirshner

J Interferon Cytokine Res 2014 Dec;34(12):923-930

Division of Therapeutic Proteins, U.S. Food and Drug Administration , Bethesda, Maryland.

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http://dx.doi.org/10.1089/jir.2013.0011DOI Listing
December 2014

New FDA draft guidance on immunogenicity.

AAPS J 2014 May 29;16(3):499-503. Epub 2014 Mar 29.

Mercer University, 3001 Mercer University Drive, Atlanta, Georgia, 30341, USA,

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http://dx.doi.org/10.1208/s12248-014-9587-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4012054PMC
May 2014

Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment.

Nat Biotechnol 2008 Aug;26(8):901-8

Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, NIH Building 29B, 8800 Rockville Pike, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1038/nbt.1484DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478093PMC
August 2008