Completing a Phase 1 clinical study is a major milestone for your development program and there are multiple considerations for the team depending on the drug product used in the study and the clinical outcome.

It is a common approach to adopt a Phase 1 appropriate formulation for the clinical study (e.g. Powder in Bottle, Solution / Suspension) to allow dose flexibility and accelerate the generation of early clinical data however this dosage form may not be suitable for Phase 2 clinical studies due to:

• Dosage form does not align with patient needs (e.g. reconstitution requirements)
• Storage or shelf-life of dosage form does not meet requirements of the study (e.g. refrigerated storage)

In most cases, a more conventional oral dosage form (tablet, capsule) is required for the Phase 2 clinical study to move towards the intended commercial format, however, maintaining unit dose flexibility as the development and clinical programme progresses through the next stages is critical.

Another challenge faced by developers on completion of the Phase 1 clinical study is the observation of sub-optimal clinical data (variable or non-linear PK or potential food effect) which requires a rapid response to understand how the formulation may be optimised to address the exposure challenge and allow the programme to move forward. This may be a stand-alone exercise or combined with the move towards the intended final dosage form.

But how do you transition smoothly, and what role does your existing CDMO and future CDMO play in achieving commercial success? 

A partnership with a CDMO can help to define and implement the best pathways and this guide explores the key considerations you need to take to ensure a successful transition, focusing on solid oral dosage forms (tablets and capsules).

Download the white paper to read more.