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

School of Medicine

Research output: Contribution to journal › Review article › peer-review

10 Scopus citations

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 1 2009

ASJC Scopus subject areas

Pharmacy
Pharmacology
Drug guides

Cite this

@article{65e3151a62744084a12a4c9ed881d78b,

title = "Performance-based monographs",

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.",

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

year = "2009",

month = may,

day = "1",

language = "English (US)",

volume = "35",

pages = "765--771",

journal = "Pharmacopeial Forum",

issn = "0363-4655",

publisher = "United States Pharmacopeial Convention Inc.",

number = "3",

}

TY - JOUR

T1 - Performance-based monographs

AU - Cecil, T. L.

AU - Williams, R. L.

AU - Abernethy, D. R.

AU - Koch, W. F.

AU - Hauck, W. W.

PY - 2009/5/1

Y1 - 2009/5/1

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.

UR - http://www.scopus.com/inward/record.url?scp=67649352683&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67649352683&partnerID=8YFLogxK

M3 - Review article

AN - SCOPUS:67649352683

SN - 0363-4655

VL - 35

SP - 765

EP - 771

JO - Pharmacopeial Forum

JF - Pharmacopeial Forum

IS - 3

ER -

Performance-based monographs

Abstract

ASJC Scopus subject areas

Other files and links

Fingerprint

Cite this