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4 Result(s)

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  1. No Access

    Article

    A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics

    A mathematical pharmacokinetic/anti-drug-antibody (PK/ADA) model was constructed for quantitatively assessing immunogenicity for therapeutic proteins. The model is inspired by traditional pharmacokinetic/pharm...

    **aoying Chen, Timothy Hickling, Eugenia Kraynov, Bing Kuang… in The AAPS Journal (2013)

  2. No Access

    Article

    Approaches to Resolve False Reporting in Neutralizing Antibody Assays Caused by Reagent Leaching from Affinity Capture Elution Solid Phase

    Insufficient drug tolerance presents a major challenge in the development of neutralizing antibody (NAb) assays for biotherapeutics. Sample pre-treatment using solid-phase extraction with acid dissociation (SP...

    Yuhong **ang, John Kamerud, Jean Donley, Katrina Olson, Teresa Caiazzo… in The AAPS Journal (2018)

  3. No Access

    Article

    Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody

    Immunogenicity is a major challenge for protein therapeutics which can potentially reduce drug efficacy and safety and is often being monitored by anti-drug antibody (ADA) and neutralizing antibody (NAb) assay...

    Yuhong **ang, Chuenlei Parng, Katrina Olson, Elena Seletskaia… in The AAPS Journal (2019)

  4. No Access

    Article

    Induction and Impact of Anti-Drug Responses Elicited by a Human Recombinant Coagulation Factor FXaI16L in Preclinical Species

    This paper presents a systemic investigation of ADA development and ADA impact of a human coagulation factor in nonclinical species during drug development and provides insights into potential implications in ...

    Chuenlei Parng, Michael Bolt, Debra D. Pittman, Teresa Caiazzo… in The AAPS Journal (2019)