NiKem Research has received authorisation to perform acute and sub-chronic toxicology studies (upto 28 days) in all rodent species for preliminary safety evaluation of novel chemical entities (NCEs) from the Italian Ministry of Health, on March 29, 2010.
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NiKem Research said that Toxicokinetic (TK) studies are allowed to correlate plasma and/or organ exposure of NCEs (and metabolites) to tolerated doses in toxicology studies.
NiKem Research has provided preclinical support through its in-vitro ADME 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 development in NiKem’s preclinical services.
Giuseppe Giardina, CEO and managing director of NiKem Research, 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 value for their outsourced drug discovery projects.”
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