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Can commercial immunoassay kits be validated for use in GLP studies?

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Can commercial immunoassay kits be validated for use in GLP studies?

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Most kits can be validated for GLP studies, but there are instances where certain kit components may require modification in order to optimize the assay for validation. However, there are some commercially available immunoassay kits that are not able to be validated for GLP studies for reasons ranging from lack of reference material to poor performance.

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