In today’s drug development landscape, efficient completion of the clinical pharmacology package is essential to ensure successful NDA submission. However, the nature of these trials, and especially human ADME studies, often require a series of specialist vendors to support program design and execution. At Quotient Sciences, we specialize in taking the strain off our customers by integrating scientific expertise built over hundreds of clinical projects, with end-to-end services for these complex programs.
This seminar will explore 15 years of delivering human ADME data through the Synthesis-to-Clinic® platform, which streamlines these programs by integrating all steps, from radiosynthesis and drug product manufacture to clinical delivery, mass balance, and metabolite profiling—often under a single contract. Whether supporting human ADME studies for New Drug Applications (NDA) or running in parallel with Phase II Proof of Concept (POC) trials, the Synthesis-to-Clinic® integrated ADME studies are enabled through the application of Translational Pharmaceutics®.
Quotient Sciences' scientific experts will also explore the construct of the drug-drug interaction (DDI) package from initial drug assessments, and in-silico evaluations, through to design of “multi-interaction” studies and DDI cocktail studies.
Clinical Pharmacology & Human ADME Studies: A Roadmap to Market
Burlington House
Piccadilly
London, London W1J 0BA
United Kingdom