ABSTRACT
This chapter discusses Bayesian methods for stability design and analysis. Stability testing is a key component in all stages of drug development. Since stability design may have significant impact on the accuracy and precision of the shelf life, selection of appropriate time points for stability testing is a key consideration in developing a stability program. There are several advantages of using Bayesian methods for stability evaluation. Stability testing can be very costly particularly when the drug product is intended for the global markets. Stability testing and establishment of robust release limit are integral parts of the lifecycle of drug development. Since 1984, several regulatory guidelines on stability testing for new drugs, biological substances, and products have been issued. A stability study was conducted to determine the shelf life of an influenza vaccine based on a potency assay, which measures log10 focus-forming units per dose.
