Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products.
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DOI: 10.4155/bio-2019-0241
Abstract: Therapeutic proteins have the potential to induce unwanted immune responses. The potential impact of immunogenicity on pharmacokinetics, pharmacodynamics, safety and efficacy are well established. Here, we analyze key aspects of current US FDA and EMA… read more here.
Keywords: regulatory guidance; antidrug antibody; analysis regulatory; guidance antidrug ... See more keywords