Acceptable, equivalent, or better: Approaches for alternatives to official compendia! procedures

W. W. Hauck, A. J. DeStefano, T. L. Cecil, D. R. Abernethy, W. F. Koch, R. L. Williams

Research output: Contribution to journalArticle

Abstract

The General Notices in the US Pharmacopeia (USP) permit analysts to use acceptable (suitable) alternatives to an official procedure. In a revision that will be effective May 1, 2009, the General Notices will require that the alternative procedure be demonstrated to give results that are equivalent to or better than those obtained by the official procedure. This Stimuli article discusses approaches for determining equivalent or better procedures. The concepts and tests discussed in this paper may become one or more USP General Chapters. The preceding Stimuli article speaks to approaches that determine an acceptable procedure without requiring a study to document equivalent or better.

Original languageEnglish (US)
Pages (from-to)772-778
Number of pages7
JournalPharmacopeial Forum
Volume35
Issue number3
StatePublished - May 2009
Externally publishedYes

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ASJC Scopus subject areas

  • Drug guides
  • Pharmacy
  • Pharmacology

Cite this

Hauck, W. W., DeStefano, A. J., Cecil, T. L., Abernethy, D. R., Koch, W. F., & Williams, R. L. (2009). Acceptable, equivalent, or better: Approaches for alternatives to official compendia! procedures. Pharmacopeial Forum, 35(3), 772-778.