Transitioning an Oral Solid Dosage Form from Phase 1 to Phase 2 Clinical Studies

Webinar overview (40 minutes)

Dr Ian Lafferty delves into the formulation, analytical, and manufacturing strategies necessary for progressing from Phase I to Phase II clinical trials. Highlighting Upperton’s data-driven UpperSolve platform, the webinar outlines how minimal API input and early decision-making can streamline development, reduce timelines, and improve the likelihood of clinical and commercial success.

Key topics covered

• Transition strategies from powder-in-bottle to tablets and capsules

• Development timelines and practical considerations for Phase II readiness

• Analytical method development and phase-appropriate validation

• Stability study design and ICH-compliant testing requirements

• Capsule vs. tablet selection and adaptable formulation approaches

• Addressing bioavailability and manufacturability challenges

• Special formulation needs for amorphous solid dispersions (ASDs)

• Real-world case studies demonstrating successful Phase I–II transitions

Register for this on-demand webinar to gain insights into optimising oral dosage forms for clinical development and ensuring your formulation is ready for scale-up and regulatory success.