Reconciling clinical data with risk: the Kathon biocide story

This chapter discusses the approach employed by Rohm and Haas Company to shepherd a microbicide through the stages of risk analysis and management, with special emphasis on the role of clinical evaluation. The risk analysis process for a microbicide with broad applications as well as varied human exposure patterns involves assiduous planning along with development and implementation of appropriate actions to monitor and reduce risk levels. The cooperation of industry and the dermatology community was instrumental in achieving the goals of the program.