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news.NiKem Research has received qualification from regional authority ASL Milano 1 of Regione Lombardia (Prot. N. 24588) to perform pharmacokinetic, metabolism and bioequivalence analyses for clinical trials on healthy volunteers on March 18, 2010, according to Italian DM 19 March 1998. AIFA (Italian Medicines Agency) is now recording NiKem Research qualification.
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NiKem Research claimed that it has provided high quality cost-effective bioanalytical support both for its in-vitro ADME and in-vivo PK services associated to various drug discovery programs and as a standalone capability.
NiKem Research said “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; new Chemical Entity (NCE) Phase I studies on healthy volunteers; clinical bioequivalence studies.
Giuseppe Giardina, managing director and CEO 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.”