The regulatory requirement to describe the pharmacokinetics and metabolism of new drug candidates provides the development team with particular challenges for molecules intended for oncology indications and for delivery via the inhaled route.
For oncology indications, it is often not feasible to perform a conventional mass balance study in healthy volunteers and it is difficult to subject severely ill patients to the rigours of residency and sample collection that are required for such studies. Quotient has recently completed the following studies to address exactly these issues:
• A combined IV microtracer/ ADME study to interrogate human dose dependent pharmacokinetics and metabolism with a drug candidate not previously dosed to healthy subjects
• A microdose study in healthy subjects with a cytotoxic molecule to generate mass balance data to support regulatory submission
Similarly, designing a human metabolism study for an inhaled drug has always involved compromise given that 14C drug delivery via the inhaled route is often impractical. Quotient has recently completed the following study to overcome this limitation:
• A combined IV microtracer / inhaled study to provide human metabolism data via the intended dose route for the intended marketed product, in addition to an assessment of absolute bioavailability
The studies were enabled using Quotient’s unique Synthesis-to-ClinicTM and Translational PharmaceuticsTM platforms. Regulatory and ethics approvals were obtained within the standard timeframes for clinical pharmacology studies in the UK.
Mark Egerton, Managing Director of Quotient Clinical, commented: “We are delighted to have achieved these milestone studies, which demonstrate our continued commitment to providing the pharmaceutical industry with innovative solutions to the challenges of drug development through our integrated 14C-enabled drug development programs.”
For more information on Quotient Clinical, 14C enabled drug development and Synthesis-to-Clinic, please call +44 (0)115 974 9000, email clinical@quotientbioresearch.com or visit www.quotientbioresearch.com/clinical.
Chrissie Walker
bcsAgency
Tel: 0115 948 6900
Email: quotient@bcsAgency.com
