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.”
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.