Excipient Toxicity and Safety

Introduction to Excipients What Are Excipients? Thomas A. Wheatley Purity of Excipients Dankward Jakel and Martin Keck History of Excipient Safety and Toxicity Charles L. Winek Regulation of Pharmaceutical Excipients Christopher C. DeMerlis Safety Evaluation of Pharmaceutical Excipients Development of Safety Evaluation Guidelines Joseph F. Borzelleca and Myra L. Weiner Routes of Exposure: Oral Lois A. Kotkoskie Routes of Exposure: Topical and Transdermal Matthew J. Cukierski and Alice E. Loper Routes of Exposure: Inhalation and Intranasal Charmille B. Tamulinas and Chet L. Leach Routes of Exposure: Parenteral David B. Mitchell Routes of Exposure: Other Carol S. Auletta Risk Assessment of Excipients Toxicokinetics and Hazard Identification Frank M. Sullivan and Susan M. Barlow Exposure Assessment David J. George and Annette M. Shipp Risk Assessment and Risk Communication Anthony D. Dayan Future Issues Harmonization of Excipient Standards Zak T. Chowhan