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 ...

Get Quantitative Methods for Traditional Chinese Medicine Development now with O’Reilly online learning.

O’Reilly members experience live online training, plus books, videos, and digital content from 200+ publishers.