title: A new approach to the safety assessment of pharmaceutical excipients. The Safety Committee of the International Pharmaceutical Excipients Council.
abstract: This article presents a set of proposed guidelines for the safety assessment of new pharmaceutical excipients. These guidelines were developed by the Safety Committee of the International Pharmaceutical Excipients Council and represent a new, scientifically based approach to establishing conditions for the safe use of proposed pharmaceutical excipients utilizing various routes of human exposure. They are based upon the best currently available toxicological science and have taken the deliberations of the International Conference on Harmonization into consideration. These guidelines were developed because there are no regulatory agency guidelines currently available which specifically address the toxicological testing of a material intended for use as an excipient in pharmaceutical preparations. Only materials which have been previously permitted for use in a pharmaceutical preparation or which have been permitted for use in foods may be considered safe under current practices. If implemented, these guidelines should expedite the review of a proposed new excipient by regulatory agencies.
authors.affiliation: Hercules Incorporated, Wilmington, Delaware 19894, USA.
authors.forename: M
authors.initials: M
authors.lastname: Steinberg
authors.forename: J F
authors.initials: JF
authors.lastname: Borzelleca
authors.forename: E K
authors.initials: EK
authors.lastname: Enters
authors.forename: F K
authors.initials: FK
authors.lastname: Kinoshita
authors.forename: A
authors.initials: A
authors.lastname: Loper
authors.forename: D B
authors.initials: DB
authors.lastname: Mitchell
authors.forename: C B
authors.initials: CB
authors.lastname: Tamulinas
authors.forename: M L
authors.initials: ML
authors.lastname: Weiner
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence / Q000592:standards*; D005079:Excipients / Q000008:administration & dosage / Q000009:adverse effects*; D017408:Guidelines as Topic; D006801:Humans; D018570:Risk Assessment
chemical_list: D005079:Excipients