Excipient Toxicity and Safety Book

Introduction to Excipients

What Are Excipients?
Thomas A. Wheatley Purity of Excipients Dankward Jäkel 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