Performance-based monographs

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

Research output: Contribution to journalReview articlepeer-review

Abstract

This Stimuli article describes a performance-based monograph (PBM) that specifies tests and acceptance criteria for articles in the US Pharmacopeia (USP) and National Formulary (NF). For selected tests of the monograph, a certified reference material (CRM) from USP would be provided to assist analysts in developing sound procedures. Availability of a default procedure in association with the PBM is considered, pros and cons of the approach are presented, and comments are solicited.

Original languageEnglish (US)
Pages (from-to)765-771
Number of pages7
JournalPharmacopeial Forum
Volume35
Issue number3
StatePublished - May 1 2009

ASJC Scopus subject areas

  • Pharmacy
  • Pharmacology
  • Drug guides

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