At the intersection of drug product development and delivery method selection come decisions about routes of administration. For a complex, large molecule biologic, what approaches to delivering it will or might work, and how will you know? In this discussion of formulation, dose, and device alignment, expert panelists Rubi Burlage (Merck), Dominick DeGrazio (GSK), and John Higgins (Drug Hunter Consulting) will join host Tom von Gunden (Drug Delivery Leader) in a discussion of key considerations that should guide your weighing of delivery options.
With primary examples applied to prefilled syringes, autoinjectors, and combination products, those considerations will include:
o How complex is the biologic formulation?
o Will delivery require high dose / high volume?
o What are the characteristics of the target patient population?
o Is there a goal of non-clinical administration, including self-administration?
o Is there a goal of moving or expanding from one delivery method to another?
