Biases in clinical trials performed for regulatory approval-Reference-Cited by-同舟云学术

Biases in clinical trials performed for regulatory approval

Published:2015-06-09 Issue:5 Volume:20 Page:437-439
ISSN:0949-1775
Container-title:Accreditation and Quality Assurance
language:en
Short-container-title:Accred Qual Assur

Author:

Krouwer Jan S.

Publisher

Springer Science and Business Media LLC

Subject

Safety, Risk, Reliability and Quality,Instrumentation,General Chemical Engineering,General Chemistry

Link

http://link.springer.com/content/pdf/10.1007/s00769-015-1145-0.pdf

Reference4 articles.

1. ISO 15197:2003 (2003) In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. International Organization for Standardization, Geneva

2. Brazg RL, Klaff LJ, Parkin CG (2013) Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol 7:144–152

3. Freckmann G, Baumstark A, Jendrike N et al (2010) System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther 12:221–231

4. Klonoff DC, Lias C, Vigersky R et al (2014) The surveillance error grid. J Diabetes Sci Technol 8:658–672

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