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25 Aug 2011

WuXi's BAS Unit Receives Bioanalytical GLP Certification

The certificate states that WuXi's BAS facility in Shanghai is able to carry out ADME, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies with respect to OECD and EU GLP principles.

WuXi AppTec's Bioanalytical Services (BAS) unit has received a certificate of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD) and the European Union (EU).

 

The certificate states that WuXi's BAS facility in Shanghai is able to carry out ADME, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies with respect to OECD and EU GLP principles. The facility underwent review on May 9-11, 2011 by Belgian authorities.

 

This represents WuXi's third successful audit of its bioanalytical lab by regulatory authorities, according to a company statement. The facility also passed a bioequivalence study inspection by the FDA in March 2009 and an inspection by China

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