This foundational statistical paper demonstrates that theoretical viral inactivation curves cannot guarantee vaccine safety, necessitating rigorous statistical consistency testing of production lots.
Inactivation curve extrapolation cannot substitute for safety testing; leaves open the need for empirical lot validation in vaccine production.
How much of each lot of vaccine must be tested to provide reasonable assurance of its safety?This paper considers some of the statistical issues associated with this question and, in the process, develops the concept of the consistency of a production process.
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Cornfield et al. (1956) studied this question.
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