Early evaluation of safety of drugs

CIT, a leading European non-clinical CRO specialised in health and safety research, announces today a new range of fast and economical services to meet the growing needs of companies developing the drugs of tomorrow. The services, grouped under the name LeadScreen, offer an extensive array of tests designed to give an early evaluation of safety of drugs thought to have development potential.
 
Currently, around 20 per cent of candidate drugs fail during standard regulatory non-clinical studies, too often due to late identification of toxicological effects. Using CIT’s LeadScreen, the early detection of potential toxicity can significantly increase the chances of success when the candidate drug goes through the later stages of non-clinical development. The speed, competitive price and efficacy of LeadScreen offers the ability to reduce considerably the financial cost and time associated with standard drug development practices.
 
The new LeadScreen services are fast. From the start of the study to delivery of the results takes only 14 days - a real competitive advantage over tests currently on the market. As well as saving time, LeadScreen (TM) presents other advantages such as its requirement for only a small quantity of the compound - and attractive pricing.
 
LeadScreen offers services that are easy to customize, standalone and entirely optional. They comprise:
 
* LeadScreen Tox allows more precise selection of the future drug candidate. Using CIT’s expertise in toxicology, genomics and biomarker analysis, LeadScreen Tox offers a multi-criteria toxicology study that can be critical in deciding which pre-selected molecules should be pursued. In a four-day predictive study, LeadScreen Tox combines the clinic (daily clinical examinations), clinical biology, histopathology, toxico-genomics, biomarker identification, in vivo micronuclei and toxico-kinetics.

* LeadScreen Genotox allows the evaluation of the genotoxicity of candidates using BlueScreen tests, mini-Ames and mini-micronucleus.

* LeadScreen Safety allows the evaluation of pharmacological safety parameters, such as QT prolongation and other cardiovascular parameters in vivo.

* LeadScreen PK allows the definition of in vivo half-life and bioavailability.

* devTox and cardioTox: LeadScreen also includes tests offered by CIT’s Wisconsin-based partner, Stemina Biomarker Discovery. These use metabolomics and embryonic human stem cells to identify biomarkers for developmental (devTox and cardiac toxicity (cardioTox).
 
“CIT’s LeadScreen enables our customers to perform research on candidate molecules included in development programs prior to their entry into the more advanced stages of pre-clinical research – and it provides pertinent data that make it easier to identify candidate drugs that have the best safety profile,” said Sophie Baratte, CEO at CIT. “Moreover, these data also allow clients better to define and conduct regulatory studies, while increasing the probability of bringing a candidate drug to market. LeadScreen is a great complement to the wide ranging safety evaluation services that CIT carries out during regulatory pre-clinical research.”
 
For more information, visit www.citox.com

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