Full Description
This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.
Examines excipients as a unique class of products and explores new procedures for determining toxicity!
A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety
identifies the differences between excipients (inactive ingredients), food ingredients, and drug products
evaluates issues of dose administration, species selection, and study design for various routes of exposure
provides detailed information on the historical uses of excipients in drug formulations
clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure
explains how data generated in toxicity models are applied to identify hazards in drug formulations
details exposure assessment to link hazard identification with risk
considers the requirements and importance of purity specifications
and much more!
Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
Contents
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
