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With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the ...
Immunogenicity assays play a vital role in evaluating the safety and efficacy of vaccines by measuring the immune response induced in vaccinated individuals, and serve as crucial tools in vaccine development, clinical trials, licensure, and post-marketing surveillance. Various methods are employed in vaccine immunogenicity assays, ranging from traditional techniques like LBAs to advanced ...
Protein precipitation is a common protocol for rapid sample clean-up and extraction of pharmaceuticals from blood samples (whole blood, plasma and serum) during drug discovery. It also allows the disruption of drug binding to proteins. Blood samples from various species such as dogs, rats, mice, and humans show variations in their compositions, but often only a single bioanalytical method covers ...