Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presentation ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

Evaluation methods rely on assumptions about how validation data and the data one wants to predict, called test data, are related. Traditional methods assume that validation data and test data are ...

Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading causes for drug withdrawals from market and compound attrition during drug development. To assess ...

WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays ...

Spanning the Gap between Synthetic Lipid Chemisty and Signal Transduction Biology Many scientists are familiar with lipids as hydrophobic molecules that form biological cell membranes. However, ...

Animal testing is often used to evaluate the potential risks, uses, and environmental impacts of chemicals. New Approach Methodologies (NAMs) are technologies and approaches that can potentially ...

In this interview, Dr. Gary Pestano and Dr. Prithwish Pal discuss the advantages ddPCR offers in molecular residual disease ...

A point-of-care (POC) high-sensitivity assay for cardiac troponin I (hs-cTnI) shows diagnostic accuracy comparable to what’s achieved by central laboratory assays and could potentially be a useful ...