chapter  4
25 Pages

Scaleup Design and Analysis

In the pharmaceutical industry it is important to ensure that a production batch can meet the USP/NF standards for the identity, strength, quality, and purity of the drug before a batch of the product is released to the market. Although a number of product tests, such as potency and dissolution testing, may be conducted for this purpose, these tests are usually done based on samples from a laboratory batch or small-scale production batch. In practice it is not clear whether the results from such a laboratory batch or small-scale production batch can be predictive of a regular scale-of-production batch. In this case, a scaleup experiment is usually employed to evaluate the drug product when the batch is scaled up according to a preplanned scaleup program.