Outsourcing of Pharmaceuticals

Authored by: Duane B. Lakings , Alicia L. Lakings

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v3-63

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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. Of the many billions of dollars the pharmaceutical companies spend per year on research and development, over a third to a half (and possibly more) is presently expended at contract service organizations (CSOs), and the amount is projected to increase in the coming years. The term CSO includes discovery and nonclinical contract research organizations (nCROs), clinical contract research organizations (cCROs), contract manufacturing organizations (CMOs), and any other organization (such as a regulatory affairs group or consortium) that provides the pharmaceutical and biotechnology industry, or the sponsor, with any of the various types of contract services.

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