Chemical and Pharmaceutical Bulletin
Online ISSN : 1347-5223
Print ISSN : 0009-2363
Notes
A Comparison of the Analysis of Covariance (ANCOVA) and Range-Based Approaches for Assessing Batch-to-Batch Variability of the Stability of Pharmaceutical Products
Sumie YoshiokaYukio AsoShigeo KojimaNicholas F. Cappuccino
Author information
JOURNALS FREE ACCESS

Volume 50 (2002) Issue 6 Pages 881-883

Details
Download PDF (43K) Contact us
Abstract

Stability data were generated by the Monte Carlo method, and batch-to-batch variability was evaluated by analysis of differences in slope and intercept according to the analysis of covariance (ANCOVA) approach recommended in the FDA Guidance. Using the same generated data, batch-to-batch variability was also evaluated by assessing the equivalence of shelf lives estimated for individual batches based on the range (Range-based approach) in order to compare the ability of the two approaches to detect stability differences among batches. The results of the study indicated that the Range-based approach can detect a 30% difference in the slope of degradation curves among batches with a similar β error as the ANCOVA approach, provided that degradation data are obtained with assay errors below 0.5. The range-based approach appears to be useful as an alternative method to ANCOVA, if it is modified such that the variance of estimates is taken into account.

Information related to the author
© 2002 The Pharmaceutical Society of Japan
Previous article
feedback
Top