Quotient Clinical Demonstrates Effective Drug Product Optimisation October 2009 Quotient Clinical, a strategic business unit of leading drug development services provider Quotient Bioresearch (“Quotient”), announces the availability of a new white paper demonstrating the advanced capabilities of the novel RapidFACT approach: an integrated formulation development, manufacture and clinical testing service. RapidFACT can be used to optimise drug products with significantly shorter timelines and reduced associated expenditure compared to traditional approaches. The new white paper, entitled “RapidFACT - a New Paradigm for the Effective Optimisation of Oral Dosage Forms”, is available to download free-of-charge via www.quotientbioresearch.com/news
A conventional drug product optimisation process involves iterative rounds of screening multiple formulation prototypes in preclinical species to identify a limited number of “lead” systems to progress into human clinical PK studies. This process is time consuming and expensive, costing over £1m and taking over 18 months. Quotient’s RapidFACT service can reduce this timeline by up to two thirds and significantly reduces associated costs.
RapidFACT exploits Quotient’s Translational Pharmaceutics platform which integrates formulation development, GMP drug product manufacture and clinical testing facilities to allow products to be manufactured and investigated in a clinical study in timeframes as short as 24 hours. Candidate formulations can be rapidly screened, selected and validated on the basis of human clinical data. This significantly improves the precision by which an optimal drug product that matches the desired target product profile can be identified.
Mark Egerton, Chief Executive Officer of Quotient Clinical comments, “The increasingly competitive nature of the pharmaceutical industry inevitably means that any approach which saves time and money and increases the chances of development success, is welcomed by our clients. We have now completed RapidFACT programs for a number of our pharma and biotech clients and the results have been very pleasing. We have clearly demonstrated our ability to accelerate early development”.
To find out more about RapidFACT or to obtain a copy of the new white paper, please visit www.quotientbioresearch.com, email clinical@quotientbioresearch.com or call Quotient Clinical on +44 (0)115 9749000 for further information.
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Quotient Bioresearch Limited
Newmarket Road
Fordham, Cambridgeshire
CB7 5WW
United Kingdom
Phone: 44 (0)115 9749000
www.quotientbioresearch.com
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