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.
Advancing the Pharmaceutical Development of Orphan Drugs for Rare Diseases
With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.