Regulatory, design, and analysis aspects of complex stability studies. US Food & Drug Administration

Drug stability studies are expensive and time consuming. Multiple batches are studied to ensure that a product will consistently remain within specifications for its entire expiration dating period. Some of these studies involve the same drug products in similar packages or in multiple strengths. Application of sound statistical design principles can reduce the amount of testing required. We extend the principles stated in the Food & Drug Administration's 1987 publication Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics to setting expiration dating periods for more complex situations.