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On Monday 21st May 2018 the US FDA published the final version of the updated Bioanalytical Method Validation (BMV) Guidance for Industry. Considering this is a pivotal guidance for conducting regulated bioanalysis, a finalized document was highly anticipated since the release of the draft version in 2013. As such, I thought I’d summarize my personal first impressions and anticipate how our community may respond and adapt. My intent is only to spur further discussion and dialogue on this important bioanalytical milestone. I don’t doubt that more substantive review and discussion from across the bioanalytical community will follow and I’ll look to delve deeper myself into the pertinent... Read More

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Bioanalytical Laboratories

Author: Costa Panagos During April 22-28, 2018, Q2 Solutions is celebrating Medical Laboratory Professionals Week, also known as Lab Week. I want to take this opportunity to acknowledge and thank our global laboratory teams for their important work and ongoing commitment to serving our patients, customers, and each other. When I first joined Q2 Solutions and toured our various sites, I noticed an inspirational sign posted in one of our laboratories. It read, “Every laboratory sample we process impacts a patient’s life. Your handling and subsequent analysis provides the essential information used to diagnose and determine treatment options.” This sign had a profound impact on me that I... Read More

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ADME , Analytics , Assay Development , Biomarkers , Central Laboratories , Companion Diagnostics , Data Integration , End-to-End Services , Genomics , Immunoassay Services , Precision Medicine , Research and Development , Translational Medicine , Vaccines

This year, the theme for World Immunization Week is “Protected Together, #VaccinesWork.” This theme brings to heart and mind the significant efforts of those who have developed life-saving vaccinations for millions of people across the globe. It also highlights the potential for a great improvement in rates of those diseases for which vaccines are not yet available. Respiratory Syncytial Virus (RSV) is the largest, most significant respiratory disease in children and the elderly for which a successful vaccine has not yet been developed. According to the Centers for Disease Control and Prevention, an average of 2.1 million outpatient visits and more than 57,000 hospitalizations among... Read More

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Vaccines