By Nanda Subbarao, Kim Huynh-Ba

Published in: Handbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices

Published on: January 1, 2009

Abstract: This chapter from the book "Handbook of Stability Testing in Pharm Development" discusses the evaluation of stability data. It follows the study information from the point that raw data is generated in the lab, calculations are performed to give test results, and test results are entered in the stability summary sheets, until data is finally entered into a stability report for submission purposes. This chapter also includes a summary of data evaluation addressed in ICH Q1E and a discussion of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations. Specification setting and shelf-life extrapolation, which are performed after evaluating stability data, are also described in this chapter.

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