It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...

When Congress passed the No Child Left Behind Act in 2001, it rewrote much of the Elementary and Secondary Education Act, increasing the amount of testing required and demanding that states hold ...

Congress must address how current federal law masks education funding disparities between low- and higher-income students by fixing the so-called comparability loophole. For appendix tables, see the ...

Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of ...

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 success or failure of the development of a biopharmaceutical product is governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, ...

Oxford Review of Education, Vol. 35, No. 2 (April 2009), pp. 205-226 (22 pages) Heated discussions about the comparability of standards between examination subjects have kept Qualification Authorities ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. To assess ...

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 ...

The EPR Test 2025 evaluated 50 multi-stage attacks covering initial compromise through lateral movement, credential theft, ...