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.
How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays whilst achieving proof-of-concept (POC)?
Choosing the appropriate dosage form for first-in-human/Phase I trials Pharmacy preparation or GMP manufacturing? Bridging to robust and scalable Phase II drug products Flexible and adaptive clinical manufacturing strategies for patient trials Integrating pharmaceutical sciences and clinical testing
Accelerating drug product development from early phase to scale up and commercialisation
This webinar covers 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.