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Strategies for Accelerating the Development of Modified Release Oral Forms

First-in-Human to Proof-of-Concept

How do I accelerate my molecule to Proof-of-Concept? Quotient is your answer.

First-in-Human to Proof-of-Concept

To identify molecules with the greatest chance of success, the transition of your molecule from candidate selection to Proof-of-Concept (POC) needs to be fast and cost-effective.

Quotient Sciences’ Translational Pharmaceutics® approach enables First-In-Human studies by transitioning your drug molecule into clinical development through to POC quickly through the integration of:

  • Formulation development, real-time adaptive GMP manufacturing and clinical research
  • Multiple assessments within a single clinical protocol (e.g., single dose, multiple dose, food effect, gender effect, POC)

For First-In-Human programs, our Translational Pharmaceutics approach:

  • Reduces time to POC
  • Minimizes your upfront chemistry, manufacturing and controls (CMC) investment
  • Increases your study flexibility and precision
  • Allows changes in formulation compositions in response to emerging clinical data
  • Customizes the supply of drug products to the needs of your POC study
  • Simplifies your supply chain

First-in-Human to Proof-of-Concept

Case studies and fact sheets

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