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Statistical aspects of the planning and analysis of collaborative studies on biological standards.
J Biol Stand. 1986 Oct; 14(4):273-87.JB

Abstract

Statistical principles play a central role in the planning and analysis of collaborative studies on biological standards. These studies are carried out to assess the suitability of proposed biological standards, which should be demonstrated to provide valid and reproducible measurements of biological potency, and to assign units of activity (for example, by calibration against an existing standard). Guidelines have been published by the World Health Organization (WHO Tech Rep Ser 1978: 626: 101-141) describing the technical and general aspects of setting up biological standards and organizing collaborative studies. This paper, which is complementary to the WHO guidelines, expands on the statistical points which need to be considered. The general design of the study, the design of individual assays, the statistical analysis of the raw data, and the presentation of the results are described.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

3558413

Citation

Kirkwood, T B., et al. "Statistical Aspects of the Planning and Analysis of Collaborative Studies On Biological Standards." Journal of Biological Standardization, vol. 14, no. 4, 1986, pp. 273-87.
Kirkwood TB, Seagroatt VA, Smith SJ. Statistical aspects of the planning and analysis of collaborative studies on biological standards. J Biol Stand. 1986;14(4):273-87.
Kirkwood, T. B., Seagroatt, V. A., & Smith, S. J. (1986). Statistical aspects of the planning and analysis of collaborative studies on biological standards. Journal of Biological Standardization, 14(4), 273-87.
Kirkwood TB, Seagroatt VA, Smith SJ. Statistical Aspects of the Planning and Analysis of Collaborative Studies On Biological Standards. J Biol Stand. 1986;14(4):273-87. PubMed PMID: 3558413.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Statistical aspects of the planning and analysis of collaborative studies on biological standards. AU - Kirkwood,T B, AU - Seagroatt,V A, AU - Smith,S J, PY - 1986/10/1/pubmed PY - 1986/10/1/medline PY - 1986/10/1/entrez SP - 273 EP - 87 JF - Journal of biological standardization JO - J Biol Stand VL - 14 IS - 4 N2 - Statistical principles play a central role in the planning and analysis of collaborative studies on biological standards. These studies are carried out to assess the suitability of proposed biological standards, which should be demonstrated to provide valid and reproducible measurements of biological potency, and to assign units of activity (for example, by calibration against an existing standard). Guidelines have been published by the World Health Organization (WHO Tech Rep Ser 1978: 626: 101-141) describing the technical and general aspects of setting up biological standards and organizing collaborative studies. This paper, which is complementary to the WHO guidelines, expands on the statistical points which need to be considered. The general design of the study, the design of individual assays, the statistical analysis of the raw data, and the presentation of the results are described. SN - 0092-1157 UR - https://www.unboundmedicine.com/medline/citation/3558413/Statistical_aspects_of_the_planning_and_analysis_of_collaborative_studies_on_biological_standards_ DB - PRIME DP - Unbound Medicine ER -