Drug Products for Investigator- Initiated Research

Investigator-sponsored clinical research is different from company-sponsored research. Pursuing an idea for a drug requires having the physical drug available. The effort applied to making that drug can be as critical as the effort applied to the clinical research. The manufacturing, packaging, and testing of the drug product is discussed in this article, including details about the facility, equipment, and personnel requirements. The control efforts to minimize drug variation have implications for the researcher and the subjects involved. The controls are extensive, and are not intuitively obvious.