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Understanding ICH Guidelines Applicable to Stability Testing

  • Kim Huynh-Ba
  • Manuel Zahn

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 While this handbook was being prepared, the FDA Stability Guidance was withdrawn; therefore, a brief discussion of the guidance status has been included.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.

Keywords

European Union Drug Product Stability Testing Drug Substance Kinetic Temperature 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.PharmalytikNewarkUSA
  2. 2.University of KarlsruheGermany

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