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Abstract:
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A validated bioassay is used to measure the potency of commercial lots, and must be accurate, precise, and fit for its intended purpose. Regulatory guidelines for the validation of a bioassay include characterization of features, such as accuracy, precision, linearity, and range. The journey of a validated bioassay typically starts in a development lab, where it may be qualified to measure the potency of clinical lots. Prior to validation, as the bioassay is transferred to new labs, the bioassay is studied and assessed across a series of small experiments. Instead of considering each study as a separate, independent report, it is proposed that, beginning with the qualification study, the accuracy and precision be continuously characterized, with each subsequent study result building from the ones that preceded. We call this method "continuous qualification". Such a proposition is naturally carried out using Bayesian statistical methods in which the historical data is used to construct prior knowledge that is blended with the current study data. Bioassay accuracy, precision, and control limits may be assessed with high confidence well ahead of commercial manufacturing.
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