BEBPA HCP 2019 -- The most critical part of developing an ELISA for measuring Host Cell Protein (HCP) impurities in Biotherapeutics is generation of specific antibodies with appropriate recognition of the total population of HCPs potentially present in the product.
Site-based observational research has many challenges. Considerable time and cost is invested in identifying suitable sites and investigators, and then managing them to ensure recruitment and research are conducted in line with the protocol and local review board requirements.
In an era of continued pressure on healthcare budgets, the role of health economic data has never been more important. Yet the contribution these data make to rational decision-making can be undermined by incomprehension, skepticism and even hostility from outsiders - including colleagues, commentators and healthcare decision-makers.
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
July Land O' Lakes 2019 -- A study assessing the feasibility of performing quantitative analysis of adalimumab in human whole blood collected using Mitra� (Neoteryx) volumetric adsorptive microsampling (VAMS) devices was conducted.
The importance of pharmacovigilance (PV) as a science, critical to both effective patient care in clinical practice and public health is growing. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Explore the current state of PV automation in light of the challenges being faced by the industry and the PV automation landscape, as well as Covance's recent innovations in automation and the how these solutions have benefited our sponsors.
Product development in health sciences is complex and costly. It can take many years to gain marketing approval for a new drug, device or diagnostic. And while there are many potential potholes along the development highway, there are also numerous opportunities to accelerate development and create benefits for all stakeholders.
