Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community

One of the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) major activities is to develop robust, validated pharmacodynamic (PD) assays. These assays allow accurate information about drug effect on intended molecular targets to be obtained in preclinical and first-in-human clinical trials to inform early go/no‐go decisions for new drug development and to identify combinations of targeted agents. In the course of these efforts, DCTD has defined the progression of an assay’s lifecycle including analytical performance validation, fitness-for‐purpose, and establishment of assay companion SOPs for specimen handling and processing.
Source: Seminars in Oncology - Category: Cancer & Oncology Authors: Source Type: research