• Corpus ID: 38791096

Method validation by phase of development: An acceptable analytical practice

  title={Method validation by phase of development: An acceptable analytical practice},
  author={Scott P. Boudreau and James S. Mcelvain and Lisa D. Martin and Thomas Dowling and Steven M. Fields},
  journal={Pharmaceutical technology},
This article provides guidance for reasonable, minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs. It is based on material developed from a PhRMA 2003 workshop about acceptable analytical practices. Additional articles from this workshop will cover dissolution of poorly soluble compounds, analytical method equivalency, and justification of specifications. 

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