DSC provides quantitative and reproducible data, making it an important assay in HOS and comparability analysis for product evaluation during development (including site-to-site and batch-to-batch ...

We're bringing back this column from May 2008 because it makes points that many still misunderstand. Specifically, assertions that one set of global standards would bring greater "comparability" ...

Forbes contributors publish independent expert analyses and insights. I am the Kester and Brynes Professor at Columbia Business School and a Chazen Senior Scholar at the Jerome A. Chazen Institute for ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...

The ability of SPR-based analysis to estimate association and dissociation rate constants is a major advantage over the traditional steady-state analysis of biomolecules. Biotherapeutics are an ...

We’re not sure if we’re having another epiphany, or merely looking at the world a little bit differently, but we have some thoughts on an area of accounting practice and theory that we’d like to share ...

Typical sites for measurement of core temperature include the pulmonary artery and midesophagus, however, these sites are available in a small minority of patients. In lieu of a direct measurement of ...

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol. On April 19, 2016, FDA issued guidance on how to implement a chemistry, manufacturing, and ...

The manufacture of biological products is a complex process that involves continual refinement throughout product development, post-approval and marketing. Reasons to alter the manufacturing process ...

“Keep your eyes on your own paper” may not be the most effective directive when it comes to reaching ESG goals. New research shows that companies that compare financial data against their peers tend ...

Identifying the culprit of unequal school funding in U.S. public schools used to be simple. When public schools derived nearly all of their revenues from local property taxes, the math was ...

At its inception over 40 years ago, the flagship Title I program of the Elementary and Secondary Education Act of 1965 was intended as the federal government’s way of giving high-poverty schools a leg ...