Project risk evaluation with design of experiment: A case of developing a generic drug analytic method development project

Abstract

Generic drugs are equivalent to branded drugs but at a cheaper price. The generic drug market is highly competitive and the drug companies tend to improve their market position by being first in the market when the patent on an original drug elapses. It is because if a company gets the first approval from Food and Drug Administration (FDA), 6 months of marketing exclusivity will be granted and the company can take the granted period to grab the lion's share of the drug's market. Thus, the time-to-market of new products is crucial to their comparative advantages. FDA requires drug companies to submit Abbreviated New Drug Application (ANDA) which contains all the information that would have been in a pioneer drug application except for safety and effectiveness. Thus a robust and efficient analytical testing method for ANDA project is essential. This study proposes a method development scheme which integrates project risk evaluation with a design of experiment to efficiently carry out the critical project under ANDA programme in order to get the revenue early on. A case is implemented to demonstrate the efficiency of this integration.