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Anatomy / Medicine / Immunogenicity / PEGylation / Vaccine / Antigen / Biologic / Antibody / Monoclonal antibodies / Biology / Immunology / Immune system


Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products U.S. Department of Health and Human Services Food and Drug Administration
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City

New York / /

Company

IgG / Garland Science Publishing / IgE / /

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IndustryTerm

individual products / to related products / administered product / protein products / efficacious therapeutic protein products / biological product / therapeutic protein product / guidance Web page / adjunctive treatment product / therapeutic protein products / /

MedicalCondition

proteinuria / obvious clinical syndrome / hemolytic anemia / disease / arthralgia / hematuria / Anaphylaxis Anaphylaxis / Anaphylaxis / fever / Allergy / serum sickness / target disease / Delayed hypersensitivity / Cytokine Release Syndrome / infectious diseases / hypersensitivity / Cytokine Release Syndrome Cytokine release syndrome / serious / acute allergic reaction / Non-Acute Reactions Anaphylaxis / rash / pure red cell aplasia / /

Organization

office of Medical Policy / U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Division of Medical Policy Development / Food and Drug Administration / office of Communication / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /

Person

Silver Spring / /

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PublishedMedium

Baseline / /

Technology

pharmacokinetics / antibodies / pharmacodynamics / /

URL

http /

SocialTag