Literature DB >> 20372993

Measurement science for food and drug monographs: toward a global system.

William F Koch1, Walter W Hauck, Susan S de Mars, Roger L Williams.   

Abstract

This article continues USP's public dialogs about applications of modern measurement science (metrology) to public or private specifications (monographs) of food and drug articles. An objective of the discussion is to promote understanding of traceability and uncertainty of measurement results. Adoption of modern metrologic principles helps ensure that a measurement of one or more property values (attributes) of a food or drug article are acceptable without regard to when (time), where (space), or how (technology) the measurement was conducted. The approach is applicable to both in-process and end-product measurements and facilitates and supports understanding of manufacturing and measurement variability relative to acceptance criteria. Application of modern metrologic principles to measurement of food and drug articles expands opportunities to ensure availability of good quality food and drugs in national and international markets.

Mesh:

Year:  2010        PMID: 20372993     DOI: 10.1007/s11095-010-0118-6

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


  3 in total

1.  The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets.

Authors:  Maria Glasgow; Shawn Dressman; William Brown; Thomas Foster; Stefan Schuber; Ronald G Manning; Samir Z Wahab; Roger L Williams; Walter W Hauck
Journal:  Pharm Res       Date:  2008-01-03       Impact factor: 4.200

2.  Metrologic approaches to setting acceptance criteria: unacceptable and unusual characteristics.

Authors:  Walter W Hauck; Darrell R Abernethy; Roger L Williams
Journal:  J Pharm Biomed Anal       Date:  2008-08-09       Impact factor: 3.935

3.  The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets: quality attributes and experimental variables contributing to dissolution variance.

Authors:  Gang Deng; Alyssa J Ashley; William E Brown; Joseph W Eaton; Walter W Hauck; Loice C Kikwai; Mark R Liddell; Ronald G Manning; Jimmy M Munoz; Pallavi Nithyanandan; Maria J Glasgow; Erika Stippler; Samir Z Wahab; Roger L Williams
Journal:  Pharm Res       Date:  2008-01-03       Impact factor: 4.200

  3 in total
  1 in total

1.  Primary and secondary reference materials for procedures to test the quality of medicines and foods.

Authors:  Walter W Hauck
Journal:  Pharm Res       Date:  2012-04       Impact factor: 4.200

  1 in total

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