ABSTRACT
INTRODUCTION Pharmaceutical development studies are conducted routinely during the development of a pharmaceutical product to better understand the properties and qualities that may need to be controlled in order to ensure consistency and quality in manufacture. As such these studies should be presented in the chemistry and pharmacy section of a marketing authorization dossier in order to convince the regulatory authorities that the applicant has a satisfactoryknowledge and understanding of the physicochemical attributes of the product. Traditionally, in the European Union (EU), information on development pharmaceutics would have been expected to be presented at the beginning of the chemistry and pharmacy dossier after the description of the proposed formulation. Such information, amplified as appropriate in the pharmaceutical expert report, provided a very useful overview of the rationale for the formulation and the properties of the drug substance pertinent to the intended therapeutic use of the product. Accordingly, a note for guidance entitled “Development pharmaceutics and process validation” (1) was produced by the EU authorities to assist applicants for marketing authorization and to expand on the more general requirements laid down in European Community (EC) Directives (2) and Volume 2B of the “Notice to Applicants” (3).
