NiKem Research Receives Authorization for Rodent Toxicology Studies
News May 07, 2010
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”.