如何为临床试验确定参考区间以排除健康个体？ - Suppr

How to define reference intervals to rule in healthy individuals for clinical trials?

作者信息

den Elzen Wendy P J, van Gerven Joop, Schenk Paul W, Uit Den Boogaard Anna, Kroon Ria, Klaassen Erica, Ballieux Bart E P B, Cobbaert Christa M

出版信息

Clin Chem Lab Med. 2017 Mar 1;55(3):e59-e61. doi: 10.1515/cclm-2016-0307.

DOI:10.1515/cclm-2016-0307

PMID:27522098

Abstract

摘要

相似文献

How to define reference intervals to rule in healthy individuals for clinical trials?

Clin Chem Lab Med. 2017 Mar 1;55(3):e59-e61. doi: 10.1515/cclm-2016-0307.

[New common reference intervals for clinical chemistry in the Nordic countries. A better basis for clinical assessment and cooperation].

Lakartidningen. 2004 Mar 4;101(10):901-5.

Clinical and professional reference guides. Table of reference intervals.

MLO Med Lab Obs. 2001 Aug;33(8 Suppl):14.

[Estimation of healthy reference intervals for elderly people through the use of outpatient data].

Rinsho Byori. 1999 Feb;47(2):165-9.

Easy verification of clinical chemistry reference intervals.

Clin Chem Lab Med. 2013 Jun 27;51(11):e279-81. doi: 10.1515/cclm-2013-0356.

Reference values: a review.

Vet Clin Pathol. 2009 Sep;38(3):288-98. doi: 10.1111/j.1939-165X.2009.00179.x.

Normality: the unreachable star?

Clin Chem Lab Med. 2004;42(7):698-701. doi: 10.1515/CCLM.2004.119.

Reference intervals: are interlaboratory differences appropriate?

Clin Chem Lab Med. 1999 Nov-Dec;37(11-12):1131-3. doi: 10.1515/CCLM.1999.165.

Prerequisites for establishing common reference intervals.

Scand J Clin Lab Invest. 2004;64(4):285-92. doi: 10.1080/00365510410006298.

Standardization of laboratory data and establishment of reference intervals in the Fukuoka Prefecture: a Japanese perspective.

Clin Chem Lab Med. 2001 Mar;39(3):256-62. doi: 10.1515/CCLM.2001.040.

引用本文的文献

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30.

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How to define reference intervals to rule in healthy individuals for clinical trials?

作者信息

den Elzen Wendy P J, van Gerven Joop, Schenk Paul W, Uit Den Boogaard Anna, Kroon Ria, Klaassen Erica, Ballieux Bart E P B, Cobbaert Christa M

出版信息

Clin Chem Lab Med. 2017 Mar 1;55(3):e59-e61. doi: 10.1515/cclm-2016-0307.

DOI:10.1515/cclm-2016-0307

PMID:27522098

Abstract

摘要

相似文献

How to define reference intervals to rule in healthy individuals for clinical trials?

Clin Chem Lab Med. 2017 Mar 1;55(3):e59-e61. doi: 10.1515/cclm-2016-0307.

[New common reference intervals for clinical chemistry in the Nordic countries. A better basis for clinical assessment and cooperation].

Lakartidningen. 2004 Mar 4;101(10):901-5.

Clinical and professional reference guides. Table of reference intervals.

MLO Med Lab Obs. 2001 Aug;33(8 Suppl):14.

[Estimation of healthy reference intervals for elderly people through the use of outpatient data].

Rinsho Byori. 1999 Feb;47(2):165-9.

Easy verification of clinical chemistry reference intervals.

Clin Chem Lab Med. 2013 Jun 27;51(11):e279-81. doi: 10.1515/cclm-2013-0356.

Reference values: a review.

Vet Clin Pathol. 2009 Sep;38(3):288-98. doi: 10.1111/j.1939-165X.2009.00179.x.

Normality: the unreachable star?

Clin Chem Lab Med. 2004;42(7):698-701. doi: 10.1515/CCLM.2004.119.

Reference intervals: are interlaboratory differences appropriate?

Clin Chem Lab Med. 1999 Nov-Dec;37(11-12):1131-3. doi: 10.1515/CCLM.1999.165.

Prerequisites for establishing common reference intervals.

Scand J Clin Lab Invest. 2004;64(4):285-92. doi: 10.1080/00365510410006298.

Standardization of laboratory data and establishment of reference intervals in the Fukuoka Prefecture: a Japanese perspective.

Clin Chem Lab Med. 2001 Mar;39(3):256-62. doi: 10.1515/CCLM.2001.040.

引用本文的文献

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30.

How to define reference intervals to rule in healthy individuals for clinical trials?

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How to define reference intervals to rule in healthy individuals for clinical trials?

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