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A Model-Based Approach to Quantify the Time-Course of Anti-Drug Antibodies for Therapeutic Proteins.
Ren, Yupeng; Li, Liang; Kirshner, Susan; Wang, Yaning; Sahajwalla, Chandrahas; Ji, Ping.
Afiliación
  • Ren Y; 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.
  • Li L; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kirshner S; Division of Biotechnology Review and Research III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sahajwalla C; 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.
  • Ji P; 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.
Clin Pharmacol Ther ; 105(4): 970-978, 2019 04.
Article en En | MEDLINE | ID: mdl-30372517
A mathematical antidrug antibody (ADA) model was developed to quantitatively assess immunogenicity for therapeutic proteins. The ADA model was built with antibody titer data in subjects from 10 clinical trials. The time course of the antibody titers was quantitatively characterized with a two-component semimechanistic model describing the double peaks of ADA titers. The relationship between antibody titer and incidence was also explored. The ADA incidences in subjects from 12 clinical trials were used for internal and external validations. The ADA titers reasonably predicted the incidence of antibody. The model-predicted elimination rate constant for antibody titer was 14.1 × 10-3  day-1 and 8.1 × 10-3  day-1 in healthy subjects and patients, respectively. This research provided a useful tool to quantitatively evaluate immunogenicity and its impact for therapeutic proteins.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacol Ther Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacol Ther Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos