Quotient Sciences’ focus is on delivering the most appropriate formulations to expedite your clinical program, through dosing within our own Phase I clinical facilities or at an external site. We work with you to support rapid progression to your first-in-human evaluation where required, ensuring that your ultimate drug product presentation goals can be seamlessly transitioned following confirmation of molecule safety and tolerability. Our formulators’ experience is built on years of work integrating formulation development and clinical evaluation. As a result, our development is based on an understanding of the intended indication including drug products designed for chronic dosing or for pediatric populations.
Our breadth of formulations developed for first-in-human studies includes:
- APIs in a bottle or capsule
- Solubility-enhanced dosage forms
First-in-Human to Proof-of-Concept
Our Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.
MEI Pharma has leveraged Quotient's Translational Pharmaceutics® platform to expedite development of its next-generation cancer therapy ME-401.
Accelerating drug product development from early phase to scale up and commercialisation
This webinar will cover a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.