Summary and Info
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.