Senior Principal Scientist Seda Pharmaceutical Development Services Greater Manchester, England, United Kingdom
Tools like BIORAM and the desire for clinically relevant specifications have brought patient centric formulation design to the mainstream. There is a tendency however to consider these as later-stage activities. The protracted timelines associated with some commercially approved long acting injectables (e.g. Bydureon) are testament to the challenges encountered when patient centricity is considered late in development – long clinical PK or even efficacy studies are required due to difficulties in establishing bioequivalence with such products (long time to steady-state leading to extended study durations and high dropout rates). Even more critical is starting with the end in mind for nanomedicines when used as targeted drug delivery systems for maximizing therapeutic index for patient benefit. Systemic concentrations of the API are rarely predictive of clinical effect therefore bridging is extremely challenging. It is therefore paramount to begin with a QTPP, defining end-product requirements before embarking on such a development.
Learning Objectives:
Have awareness of types of formulations that would benefit from the use of QTPP
Have awareness of the difficulties of demonstrating bioequivalence for long acting injectables and complex medicines
Consider patient needs at the heart of designing formulations by defining QTPP before embarking on development especially for long acting injectables
