ST. LOUIS, Sept. 15, 2015 /PRNewswire/ -- Sigma-Aldrich
Corporation (NASDAQ: SIAL) today announced that the
Cerilliant® brand within its Applied Diagnostics and
Testing business segment now offers the first-ever reference
solutions for qualitative evaluation of drug interferences in a
testing laboratory's analytical methods. These seven
multi-component solution mixes contain more than 50 of the most
routinely monitored over-the-counter (OTC) and prescription drugs.
Cerilliant offers the seven mixes separately or as a kit for added
convenience.
Regulations for drug bioanalysis, including the Clinical
Laboratory Improvement Amendments (CLIA), as well as the US FDA
Bioanalytical Method Validation Guidance, state that manufacturers
of laboratory-developed tests (LDTs) must determine the effect of
interfering substances during design, development, and validation
of an analytical method.1,2 The presence of interfering
substances, which often includes drugs and their metabolites,
impacts measurement accuracy of the analyte of
interest.1,2 Interfering compounds originate from many
sources including sample matrix, contaminants inadvertently
introduced during handling or sample preparation, and samples from
patients on multiple drug regimens.1,2
The importance of identifying interfering substances is critical
for numerous testing applications ranging from therapeutic drug
monitoring (TDM), confirmatory drug testing, and forensic analysis
to bioavailability (BA)/bioequivalence (BE) and pharmacokinetic
(DMPK) studies.
To learn more about this new offering, visit Cerilliant
Reference Materials.
About Cerilliant: Cerilliant Corporation, located in
Round Rock, Texas, is a global
leader in providing certified reference standards for critical
applications. The company has been providing Certified Reference
Materials for more than 35 years. Cerilliant offers more than 3,000
catalog products and a full range of custom products and services
that address the stringent and complex requirements of the
pharmaceutical, clinical diagnostic, clinical/forensic toxicology,
and natural products industries. Cerilliant sustains a modern,
robust quality system, which incorporates cGMP, GLP, and ISO
requirements. The company is accredited to ISO Guide 34 and ISO/IEC
17025, is certified to ISO 13485 and ISO 9001, and is compliant
with ISO 15194. Cerilliant Corporation is a subsidiary of
Sigma-Aldrich.
For more information about Cerilliant, please visit
www.cerilliant.com.
About Sigma-Aldrich: Sigma-Aldrich, a leading Life Science and Technology
company focused on enhancing human health and safety, manufactures
and distributes 250,000 chemicals, biochemicals and other essential
products to more than 1.4 million customers globally in research
and applied labs as well as in industrial and commercial markets.
With three distinct business units - Research, Applied and SAFC
Commercial - Sigma-Aldrich is committed to enabling science to
improve the quality of life. The Company operates in 37 countries,
has approximately 9,700 employees worldwide and had sales of
$2.79 billion in 2014.
For more information about Sigma-Aldrich, please visit its
website at www.sigma-aldrich.com.
Sigma-Aldrich, Cerilliant,
Snap-N-Spike, and Snap-N-Shoot are registered trademarks of
Sigma-Aldrich Co. LLC or an affiliated company.
1.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901657/
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2.
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http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf
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SOURCE Sigma-Aldrich Corporation