6 September 2011 - Quotient Clinical, a business unit of Quotient Bioresearch (Quotient), today announced that absolute bioavailability data from an ivMicrotracerTM study has been used to support a submission for regulatory drug approval. The study was performed on behalf of Bristol Myers Squibb in support of OnglyzaTM (saxagliptin), a new medicine for Type 2 Diabetes.
Results from the study were recently presented at the 12th Annual Land O’Lakes Bioanalytical Conference: Agency and Industry Perspectives on Biomarkers, Bloodspots and Beyond (Merrimac, WI, July 11-15, 2011)1. Data generated in the study were included in regulatory filings to the Australian Therapeutic Goods Administration (TGA) which has resulted in drug approval2.
Applying ivMicrotracer techniques in clinical studies allows intravenous PK and absolute bioavailability data to be generated within five months and at a fraction of the cost compared to traditional approaches. In addition, ivMicrotracer techniques can be used in stand-alone studies, or integrated into any standard early development study, maximising the flexibility for generating these data.
Mark Egerton, MD of Quotient Clinical, commented: “We are delighted to have supported Bristol Myers Squibb on this study. ivMicrotracer is a standard component of our development “toolbox”, allowing us to efficiently generate key supporting pharmacokinetic data sets for drug development teams.”
1: Achieving Regulatory Approval: Overcoming Bioanalytical Challenges in an Onglyza® Micro-tracer Absolute Bioavailability Study with Accelerator Mass Spectrometry, Xiaohui (Sophia) Xu et al, Research & Development, Bristol-Myers Squibb, Lawrenceville,NJ, USA (July 2011)
2: Australian Public Assessment Report for Saxagliptin Hydrochloride, Proprietary Product Name: Onglyza, Submission No: PM-2008-03469-3-5, Sponsor: Bristol-Myers Squibb Australia Pty Ltd (April 2011)