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.
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