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Quotient Bioresearch to Highlight Integrated Early Stage Drug Development Platforms at FIP Pharmaceutical Sciences World Congress 2010


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Quotient Bioresearch will be highlighting its unique Translational Pharmaceutics and Synthesis-to-Clinic platforms at FIP Pharmaceutical Sciences World Congress 2010 in association with AAPS Annual Meeting & Exposition, New Orleans, 14-18 November, on booth #3019.

The Translational Pharmaceutics platform has redefined early development processes by integrating the development and provision of drug products (formulation development, pharmaceutical analysis and GMP manufacturing) with clinical testing.

The transition of molecules from discovery to the First-in-Human programme can be streamlined and accelerated. The RapidFACT service, part of the Translational Pharmaceutics platform, is used to optimize drug products prior to full development, reducing timelines and associated costs by more than fifty percent.

Quotient's Synthesis-to-Clinic platform is designed to support its 14C enabled drug development services, including clinical microdose, microtracer and drug metabolism studies. Incorporating a full spectrum of radiosynthesis, preclinical and clinical capabilities, it provides a flexible and integrated process, delivering significant efficiencies to customers. Innovations in the process of 14C radiolabelling ensure that all requirements in a development project can be satisfied through a single synthesis campaign.

Quotient will also be presenting five posters covering a range of topics including:

• Addressing the challenges of poor solubility: Rapid development and clinical evaluation of a lipid based formulation to enhance oral bioavailability of amuvatinib (MP-470, co-authored with Supergen).

• Quality Standards for 14C API for use in human clinical studies

• Determination of AZP-502, an 8 aa synthetic peptide for treatment of type 2 diabetes mellitus and two of its metabolites in rat and dog plasma using LC-MS/MS

• Elucidation of the relative bioavailability of a drug candidate from different regions of the human gastrointestinal tract (co-authored with Merck)

• Applications of Therapeutic Range Exploratory Approaches from ICH M3(R2) (co-authored with Merck).
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