Abstract
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.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
International Conference on Harmonization (2003) Q1A(R2): Stability testing of new drug substances and products (second revision).
International Conference on Harmonization (2003) Q1E: Evaluation of stability data.
PhRMA CMC Statistics and Stability Expert Teams (April 2003) Identification of out-of-trend stability results. Pharm Technol pp 38–52.
FDA (1998) Guide to inspection of quality control laboratories.
FDA/CDER (October 2006) Guidance for industry: Investigating out-of-specification (OOS) test results for pharmaceutical production.
International Conference on Harmonization (1999) Q6A: Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances.
International Conference on Harmonization (1999) Q6B: Specifications: test procedures and acceptance criteria for biotechnological/biological products.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Springer Science+Business Media, LLC
About this chapter
Cite this chapter
Subbarao, N., Huynh-Ba, K. (2009). Evaluation of Stability Data. In: Huynh-Ba, K. (eds) Handbook of Stability Testing in Pharmaceutical Development. Springer, New York, NY. https://doi.org/10.1007/978-0-387-85627-8_13
Download citation
DOI: https://doi.org/10.1007/978-0-387-85627-8_13
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-85626-1
Online ISBN: 978-0-387-85627-8
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)