COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union
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DOI: 10.1002/cpt.2225
Abstract: The coronavirus disease 2019 (COVID‐19) pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct, and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance… read more here.
Keywords: regulatory guidance; european union; management; covid ... See more keywords
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