Abstract
Recent international harmonization efforts such as the International Conference on Harmonization (ICH) Harmonized Tripartite Guideline: Q6A, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances have provided general guidance for setting specifications for new drug substances and drug products, but have not provided statistical methods for integrating stability results into the process. The only statistical methods are those provided in the ICH Harmonized Tripartite Guideline: Q1(R), Stability Testing of New Drug Substances and Products (Revised guideline), which are essentially the same as those contained in the 1987 U.S. Food and Drug Administration (FDA) Guidelines for Submitting Documentation for the Stability of Human Drugs and Biologics. Although these methods are widely used, they have continued to be a source of controversy, and they are unsuitable for establishing specifications at the time of submission.
This paper provides a new computational method for determining shelf life, expiry limits, and release limits using random slopes based upon Least Squares ANOVA Estimators. Examples are provided to illustrate how the new method may be used to assist in setting specifications according to the recommendations in Q6A.
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