Excipient Toxicity and Safety edited by Myra Weiner and Lois Kotkoskie

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Excipient Toxicity
and Safety

edited by Myra Weiner
and Lois Kotkoskie

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 Councils (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.


Introduction to Excipients

Safety Evaluation of Pharmaceutical Excipients

Risk Assessment of Excipients

Future Issues

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