Transitioning an Oral Solid Dosage from Phase 1 to Phase 2 clinical studies: Key formulation challenges and strategies

February 26th 2025 – 3pm (GMT) / 10am (ET)

Transitioning an Oral Solid Dosage from Phase 1 to Phase 2 clinical studies: Key formulation challenges and strategies

February 26th 2025 – 3pm (GMT) / 10am (ET)

Addressed Challenges

  • Navigating Pharmacokinetic (PK) / Pharmacodynamic (PD) outcomes from a Phase 1 clinical study.
  • How to address formulation challenges presented by Phase 1 sub-optimal data.
  • The steps required to transition from a phase appropriate simple formulation to a conventional oral solid dosage form.

Learning Objectives

  • Development timelines and strategies for transitioning to a Phase 2 clinical study.
  • Successful formulation optimisation strategies of solid oral dosage forms.
  • An understanding what to look for when engaging with a CDMO

Dr. Ian Lafferty

Chief Technical Officer, Upperton

Ian has 25 years’ technical, operational experience gained in early phase pharmaceutical development, encompassing the formulation design and development, process optimisation and manufacture of a wide range of dosage forms including oral solids, nasal drug delivery, inhaled powders, suspensions and injectables with a focus on challenging molecules, enabling technologies and high potent handling. Ian also has significant experience in facility design and management. Ian has previously held senior management and executive roles at a number of emerging and growing CDMOs, providing strategic and operational leadership to ensure excellence in all aspects of providing pharmaceutical services.
Read More >>>

<span>By ticking this box, you consent to receiving communications from Upperton related to this topic and other products or services within their portfolio</span>

Dark