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In drug development, assays are test systems that gauge the effects of chemical compounds on certain cellular, molecular, or biochemical processes. They are a vital step in modern pharma research that pushes drugs to market faster. These are just three of the steps to take toward reliable and replicable assaydevelopment.
Our solutions include standalone services or integrated programs, providing assaydevelopment and top-quality data for toxicokinetic (TK) , pharmacokinetic (PK), and pharmacodynamic (PD) determinations to support your nonclinical and clinical studies. Image blog-thumbnail-bioanalytical-platform-selection_0.png
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). By Holly N.
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