ABSTRACT
Outsourcing of some, most, or all of pharmaceutical development, which includes drug discovery, developability assessment, preclinical/nonclinical development, clinical development (Phases 1, 2, and 3), and manufacturing (drug substance and drug product) is now a common practice for most pharmaceutical and biotechnology companies, the large ones, the smaller ones, and the virtual ones. This entry reviews the history of outsourcing in the pharmaceutical industry and then discusses more specifically the outsourcing of preclinical/nonclinical and clinical drug development.
