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.”
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
