Pharmaceutical project milestones

The major milestones of a pharmaceutical project FDA submission and first lot to stock ... 

Milestone charts consist of a tabulation of major drug development milestones. Whereas the Go/No-Go decisions discussed previously are very project specific development milestones are much more generic and can usually be applied to a wide variety of projects. Typical milestones for pharmaceutical development are shown in Table 27.10. 

Pharmaceutical development projects consist of phases, technology transfer processes, milestones, and problemsolving cycles. Understanding these basic building blocks... 

The main problem with this approach is that accurate data on the costs and time required to reach specific milestones in the R D process, and rates of success or abandonment along the way, are proprietary. Researchers must depend on the ability and willingness of companies to supply detailed data on R D project costs and histories. Hansen and DiMasi relied on surveys of 14 and 12 U.S.-based pharmaceutical fins, respectively, that were willing to provide estimates of R D outlays and timing for the samples of newly synthesized NCEs. The researchers could not... 

---