A NEW APPROACH TO THE SAFETY ASSESSMENT OF PHARMACEUTICAL EXCIPIENTS

This article presents a set of proposed guidelines for the safety asse ssment of new pharmaceutical excipients. These guidelines were develop ed by the Safety Committee of the International Pharmaceutical Excipie nts Council and represent a new, scientifically based approach to esta blishing conditions for the safe use of proposed pharmaceutical excipi ents utilizing various routes of human exposure. They are based upon t he best currently available toxicological science and have taken the d eliberations of the International Conference on Harmonization into con sideration. These guidelines were developed because there are no regul atory agency guidelines currently available which specifically address the toxicological testing of a material intended for use as an excipi ent in pharmaceutical preparations, Only materials which have been pre viously permitted for use in a pharmaceutical preparation or which hav e been permitted for use in foods may be considered safe under current practices, If implemented, these guidelines should expedite the revie w of a proposed new excipient by regulatory agencies. (C) 1996 Academi c Press, Inc.