Analytical Framework for Examining the Value of Antibacterial Products. 4.2.4 Pre-clinical, Clinical, BLA Submission Success Probabilities

04/15/2014

Success probabilities (phase transition probabilities) applicable to vaccines were found in Struck, 1996.  These were used as likely point estimates in the model, bounded as follows:

  • Pre-clinical: Lower bound of 27.0 percent, upper bound of 77.0 percent, likely point estimate of 57.0 percent,
  • Phase 1: Lower bound of 52.0 percent, upper bound of 92.0 percent, likely point estimate of 72.0 percent,
  • Phase 2: Lower bound of 59.0 percent, upper bound of 99.0 percent, likely point estimate of 79.0 percent,
  • Phase 3: Lower bound of 51.0 percent, upper bound of 91.0 percent, likely point estimate of 71.0 percent, and
  • BLA Approval: Lower bound of 76.0 percent, upper bound of 99.0 percent, likely point estimate of 96.0 percent.

View full report

Preview
Download

"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®