Chapter 13
Stability Analysis for Drug Products with Multiple Components
13.1 Introduction
For every drug product in the marketplace, the US FDA requires that an expiration dating period (or shelf life) must be indicated on the immediate container label. The shelf life is defined as the time interval at which the characteristics of a drug product (e.g., strength) will remain within the approved specifications after manufacture. Along this line, Shao and Chow (2001b) studied several statistical procedures for estimation of drug shelf life. Before a shelf life of a drug product can be granted by the FDA, the manufacturers (drug companies) need to demonstrate that the average drug characteristics can meet the approved specifications during the ...
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