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Administration of biopharmaceutical products can generate immune response that may severely impact the safety or efficacy of the products. Immunogenicity evaluation, required by regulatory agencies, relies on well developed and validated assays. Key to such assay development is the determination of a cut point during assay validation. Although many methods(More)
Biotherapeutic proteins induce undesired immune responses that can affect drug efficacy and safety. For this reason, immunogenicity assessment is an integral part of drug development and is mandated by the regulatory authorities. Immunogenicity is typically evaluated by a tiered approach consisting of a screening assay followed by a competitive inhibition(More)
The Bliss independence model is widely used to analyze drug combination data when screening for candidate drug combinations. The method compares the observed combination response (Y(O)) with the predicted combination response (Y(P)), which was obtained based on the assumption that there is no effect from drug-drug interactions. Typically, the combination(More)
Administration of biological therapeutics can generate undesirable immune responses that may induce anti-drug antibodies (ADAs). Immunogenicity can negatively affect patients, ranging from mild reactive effect to hypersensitivity reactions or even serious autoimmune diseases. Assessment of immunogenicity is critical as the ADAs can adversely impact the(More)
Past decades have seen a rapid growth of biopharmaceutical products on the market. The administration of such large molecules can generate antidrug antibodies that can induce unwanted immune reactions in the recipients. Assessment of immunogenicity is required by regulatory agencies in clinical and nonclinical development, and this demands a well-validated(More)
We provide an explicit asymptotic method to evaluate the performance of different response-adaptive randomization procedures in clinical trials with continuous outcomes. We use this method to investigate four different response-adaptive randomization procedures. Their performance, especially in power and treatment assignment skewing to the better treatment,(More)
BACKGROUND The Problem formulation, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk attitude, and Linked decisions (PrOACT-URL) framework and multiple criteria decision analysis (MCDA) have been recommended by the European Medicines Agency for structured benefit-risk assessment of medicinal products undergoing regulatory review. (More)