| Commercial Pressures
The need to take products through to the market rapidly is driven by patent expiry and the loss of time on the market at peak sales. The need to recoup costs in an increasingly price-conscious market also drives cost containment during the development of the product. There is still a need to meet the standards set out by the regulatory authorities. The approach to the optimal route to the market differs between small and large companies. A large profitable organisation is more likely to focus on speed to market, but may not have the co-ordinated infrastructure to direct early development towards this aim. A small company will be concerned with rapid progression into Phase I and II trials and compromises are inevitable. In either case, the early phase process may not be applicable to large-scale or commercial manufacture.The rapid development of a process for use in Phase I or II can lead to considerable, lengthy re-development of the process when facing the requirements of process validation for Phase III. |
