SPECIFICATIONS FOR THE DESIGN OF DOSAGE F ORMS - REPORT OF AN SFSTP COMMISSION

The need to elaborate specifications for the development of new dosage forms appears as a prerequisite to quality control. This document mus t be presented as a contract between the different persons involved in the project and be capable of evolving during the different developme nt phases. It must enable the formulation scientist to clearly define the objectives and key points of the new dosage form development. Earl y data necessary to elaborate these specifications are of scientific, economic, commercial, industrial, regulatory and environmental natures .