Performance-based monographs

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

Performance-based monographs

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

Research output: Contribution to journal › Review article › peer-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 language	English (US)
Pages (from-to)	765-771
Number of pages	7
Journal	Pharmacopeial Forum
Volume	35
Issue number	3
State	Published - May 2009
Externally published	Yes

ASJC Scopus subject areas

Pharmacy
Pharmacology
Drug guides

Cite this

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author = "Cecil, {T. L.} and Williams, {R. L.} and Abernethy, {D. R.} and Koch, {W. F.} and Hauck, {W. W.}",

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AU - Cecil, T. L.

AU - Williams, R. L.

AU - Abernethy, D. R.

AU - Koch, W. F.

AU - Hauck, W. W.

PY - 2009/5

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N2 - 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.

AB - 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.

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M3 - Review article

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JO - Pharmacopeial Forum

JF - Pharmacopeial Forum

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ER -

Performance-based monographs

Abstract

ASJC Scopus subject areas

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