Sponsors also need to conduct non-clinical work starting with the beginning of Phase 2 through product launch. These involve toxicological studies in up to 2 species that include qualification of final synthetic processes, reproductive toxicity studies, and susceptibility test development. According to experts and drug sponsors, the cost of all such non-clinical work can range from $3.4 to $4.0 million. In the model, we estimate the average cost of non-clinical work at $3.7 million.
View full report
"rpt_antibacterials.pdf" (pdf, 1.43Mb)
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®
