Abstract
This chapter discusses International Conference of Harmonization (ICH) guidelines that are related to the Stability Sciences. It gives a brief history of how the Q1A was initiated. A summary of Q1A(R2) discusses thoroughly the current regulations that the industry supports and practices. While this handbook was being prepared, the FDA Stability Guidance was withdrawn; therefore, a brief discussion of the guidance status has been included. A discussion of mean kinetic temperature is included for a basis of understanding stability testing conditions.
With Contributions from: Robert Seevers, Eli Lilly and Company
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USP 30–General Chapter<1150>Pharmaceutical stability.
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Huynh-Ba, K., Zahn, M. (2009). Understanding ICH Guidelines Applicable to Stability Testing. 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_3
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DOI: https://doi.org/10.1007/978-0-387-85627-8_3
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