Scientific Publications by FDA Staff

J Biopharm Stat 2014 Oct 30 [Epub ahead of print]

Using Tolerance Intervals for Assessment of Pharmaceutical Quality.

Dong X, Tsong Y, Shen M, Zhong J

In quality control of drug products, tolerance intervals are commonly used methods to assure a certain proportion of the products covered within a pre-specified acceptance interval. Depending on the nature of the quality attributes, the corresponding acceptance interval could be one-sided or two-sided. Thus, the tolerance intervals can also be one-sided or two-sided. To better utilize tolerance intervals for quality assurance, we reviewed the computation method and studied their statistical properties in terms of batch acceptance probability in this paper. We also illustrate the application of one-sided and two-sided tolerance, as well as two one-sided test through the examples of dose content uniformity test, delivered dose uniformity test, and dissolution test.