PPT Slide
- Based on the available literature, current in vitro tests may predict lung deposition but BE predictability has not been shown
- In vitro tests described in current draft BA/BE Guidance are not necessarily more relevant or discriminating than clinical studies for BE assessment
- Systemic PK/PD estimates systemic exposure (i.e., safety) but does not estimate local delivery (i.e., efficacy and local tolerance).
- Efficacy assessments alone cannot establish in vivo BE since they will not assure comparable safety (systemic exposure).
- Because all of the preceding statements apply equally to solutions and suspensions, the assumption that in vitro studies alone are sufficient for BE of solutions is unfounded. The Guidance should not distinguish between nasal suspensions and solutions for in vivo BE.