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NiKem Research Receives Authorization for Rodent Toxicology Studies

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NiKem Research has announced that it has received on March 29th 2010, from the Italian Ministry of Health (Decree N. 69/2010-B), the authorization to perform acute and sub-chronic toxicology studies (upto 28 days) in all rodent species for preliminary safety evaluation of novel chemical entities (NCEs).

Toxicokinetic (TK) studies are also allowed to correlate plasma and/or organ exposure of NCEs (and metabolites) to tolerated doses in toxicology studies.

NiKem Research has, for many years, provided high quality and cost-effective preclinical support through its in vitro ADME(T) and in vivo PK platform not only for numerous drug discovery programs but also as a standalone capability. The availability of acute and sub-chronic toxicology assessment represents a further and exciting development in NiKem’s established high quality preclinical services.

Giuseppe Giardina, CEO & Managing Director of NiKem, said “The capability to introduce toxicology studies to the set of services being offered to our clients is a crucial step in the continuing expansion of our preclinical development services; our clients are delighted to fully exploit the one-stop-shop model and perceive this addition as a great value for their outsourced drug discovery projects”.