NiKem Research Receives Qualification for Bioanalysis of Clinical Samples
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|Tuesday, 13 April 2010 14:00 (UTC + 2)|
Baranzate, Italy, April, 13th 2010 / b3c newswire / - NiKem Research is pleased to announce that it has received on March 18th 2010, from the regional authority ASL Milano 1 of Regione Lombardia (Prot. N. 24588), the qualification to perform Pharmacokinetic, Metabolism and Bioequivalence analyses for clinical trials on healthy volunteers, according to Italian D.M. 19 March 1998. AIFA (Italian Medicines Agency) is now recording NiKem Research qualification.
NiKem Research has, for many years, provided high quality cost-effective bioanalytical support both for its in vitro ADME(T) and in vivo PK services associated to various drug discovery programs and as a standalone capability. We are now able to offer our bioanalysis as a GLP service to not only support our clients preclinical PK and toxicology, but also our clients clinical studies. Our new capability allows us to analyse biological samples from clinical studies to supply certified bioanalyses for:
• Method development and validation by HPLC-UV or UPLC/MS/MS;
Giuseppe Giardina, CEO & Managing Director of NiKem, said “This new set of services is another important step in NiKem’s continuing expansion of its high quality and cost effective platform to support progression of our clients’ drug discovery programmes into the clinic”.
Dr. Massimo Dondio