ABSTRACT
This chapter discusses the United States Pharmacopeia guidelines, ASTM E2810 and PTI-TOST are provided along with the Bayesian counterparts and extensions. Content uniformity is a measure of the amount of active pharmaceutical ingredient in the units of a batch of drug product. Though currently accepted, content uniformity tests by regulatory agencies are Bayesian in nature. Bayesian approaches can be extremely useful in assessing batch and process performance against these tests as well as in addressing more complex data structures when applying these tests. As for issues with informative priors, we agree that one must take care not to overwhelm the assayed results from sampled units of a new batch with historical information. On the other hand, there should also be room to debate the level of historical data that may be incorporated when declaring whether or a batch exhibits a content uniformity.
