Long abstract

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The purpose of this detailed background review document is to provide a critical summary of the published scientific literature available as of August 2006, in support of the standardization and validation of the rodent Hershberger assay (Hershberger et al., 1953).  The validation process of a test method includes:
• Standardization of the study design, protocol, and standard operating procedures (SOPs).
• Testing the export of the protocol to obtain reproducible results among qualified laboratories.
• Testing the intra- and interlaboratory variability of the endpoints over time.
• Regulatory acceptance.