ABSTRACT
This chapter discusses the organization, relationships, and functioning of product development in the clinical research process. Product development provides the interface between preclinical research and the manufacture and distribution of a pharmaceutical product in commerce, the culmination of clinical research and the endpoint of pharmaceutical research and development (R&D). The end product of R&D is a pharmaceutical dosage form along with the process for its manufacture, the documentation covering its manufacture and the specifications and test methods relevant to identity, strength, quality, stability, bioavailability, and other attributes which may affect its usefulness in therapy. Stability studies are vital for predicting product performance and choosing among alternative formulations, for use in establishing expiration dating and for obtaining data to satisfy regulatory authorities. Formulation, manufacture, and distribution of clinical supplies usually is a function of Product Development. Clinical Pharmaceutical Operations participates in the review of draft protocols for clinical study or investigational new drug products.
