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.
Developing an Oral Modified Release (MR) Formulation - Challenges and Considerations for Achieving Success
Join us and learn how to overcome challenges in order to deliver a successful MR formulation. Using case studies, we will describe the specialized formulation technologies that are available in order to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize modified release formulation compositions in real-time.
Overcoming the Challenge of Poorly Soluble Drugs
How to Optimize Enabled Drug Products with Rapid Formulation Development and Clinical Testing (RapidFACT®).