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News

Quotient consolidates 14C enabled drug development solutions

Quotient Clinical : 03 February, 2012  (Company News)
Quotient Clinical, a business unit of Quotient Bioresearch, is strengthening the company's position as a leader in 14C enabled clinical drug development by manufacturing and dosing its 50th intravenous drug product using a rapid aseptic manufacture approach that has been reviewed and approved by the UK MHRA.
Developed as part of the company's innovative translational pharmaceutics platform, Quotient manufactures 'fit for purpose' intravenous drug products to GMP for 'real-time' dosing at its clinical facility in Nottingham, UK.

 

The approach enables Quotient's customers worldwide, which include the world's top pharmaceutical firms as well as small to medium-sized companies, to generate intravenous human pharmacokinetic and absolute bioavailability data more rapidly and cost effectively, to support exploratory drug development and regulatory approval.

 

In parallel, Quotient has also successfully delivered its 21st programme using its Synthesis-to-Clinic (S2C) platform.

 

S2C is a platform that integrates all of the components required for 14C enabled drug development, including 14C API synthesis, preclinical and clinical testing, through to data analysis and reporting. To date, the major application of this 'coming of age' platform has been in the delivery of human clinical mass balance and metabolism data to support regulatory submissions.

 

Mark Egerton, Managing Director of Quotient Clinical, commented:  "With the growing number of microdose and microtracer applications, and the increased importance of human metabolism data, 14C enabled drug development is becoming increasingly important to our customers".

 

"We are committed to providing innovative services to ensure that these programs of work are delivered in a high quality, and time and cost effective manner".
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