Evaluation of Stability Data

  • Nanda Subbarao
  • Kim Huynh-Ba


This chapter discusses the evaluation of stability data. It follows the \hbox{stability} 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.


Control Chart Drug Product Drug Substance Acceptance Criterion Stability Data 
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    International Conference on Harmonization (2003) Q1A(R2): Stability testing of new drug substances and products (second revision).Google Scholar
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    International Conference on Harmonization (2003) Q1E: Evaluation of stability data.Google Scholar
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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Biologics Consulting Group, Inc.PlainsboroUSA
  2. 2.Pharmalytik ConsultingNewarkUSA

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