During assay development an initial testing protocol to be used for the pre-validation studies is created. The testing protocol contains detailed, step-by-step instructions for conducting an assay. The steps involved in assay development typically include:
Scientists review information and data obtained through past research to develop an initial testing protocol and prepare detailed review papers (DRP). A detailed review paper (DRP) explains the purpose of an assay, the context in which an assay will be used, the scientific principles that form the basis for the assay, and compares the results of various protocols when available. In general, the DRP reviews the scientific literature for candidate protocols; compares them with respect to meeting the purpose, cost and other practical considerations; identifies their developmental status and information needs; and recommends an initial protocol for initiation of pre-validation. EPA, with input from the EDMVS, uses the DRP as the primary basis for deciding what test methods to move into pre-validation.
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