ABSTRACT
The major objective of the product optimisation stage is to ensure that the product selected for further development (the intended commercial product) is fully optimised and complies with the design specification and critical quality parameters described in the Product Design Report (refer to Chapter 5). The key outputs from this stage of development will be
• a quantitative formula defining the grades and quantities of each excipient and the quantity of candidate drug;
• defined pack;
• defined drug, excipient and component specifications; and
• defined product specifications.
