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.
ISSX 2019 -- Potential drug-drug interactions (DDI) mediated by inhibition of uridine di-phospho-glucuronosyltransferase (UGT) enzymes are of increasing focus.
AACC 2019 -- Calprotectin is a calcium-heterodimer protein which is abundant in the cytoplasm of neutrophils. This is a biomarker with good sensitivity and specificity in case of inflammatory Bowel disease (IBD) which is a chronic inflammatory gut.
AACC 2019 -- Symmetric and asymmetric dimethylarginine (SDMA and ADMA) are metabolites of the post-translational modification of arginine residues in histones. SDMA is produced by all body tissues and is cleared almost exclusively by the kidneys, making it an attractive biomarker for the evaluation of renal function.
AACC 2019 -- Hepatotoxicity is an ongoing focus for drug development. Drug-induced liver injury (DILI) figures prominently in the termination of candidates for new drug applications to the FDA and other regulatory authorities.
AACC 2019 -- The requirements from IFCC (International Federation of Clinical Chemistry) to qualify a cardiac Troponin assay to be qualified as a high sensitive assay are that the, Assay must have analytical imprecision of 10% at the 99th percentile, Assay must be able to measure cTn above the LOD in >50% of the patients and the 99th percentile should b
