Quotient Announces the First Use of ivMicrotracer to Support a Regulatory Drug Approval Submission
Quotient Clinical
announced that absolute bioavailability data from an
iv
MicrotracerTM 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.
Data generated in the study were included in regulatory filings to the Australian Therapeutic Goods Administration (TGA) which has resulted in drug approval.
Applying
iv
Microtracer 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,
iv
Microtracer 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.
iv
Microtracer is a standard component of our development “toolbox,” allowing us to efficiently generate key supporting pharmacokinetic data sets for drug development teams.”
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