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

1. Introduction to Excipients
   • What Are Excipients?
   • Purity of Excipients
   • History of Excipient Safety and Toxicity
   • Regulation of Pharmaceutical Excipients

2. Safety Evaluation of Pharmaceutical Excipients
   • Development of Safety Evaluation Guidelines
   • Routes of Exposure: Oral
   • Routes of Exposure: Topical and Transdermal
   • Routes of Exposure: Inhalation and Intranasal
   • Routes of Exposure: Parenteral
   • Routes of Exposure: Other

3. Risk Assessment of Excipients
   • Toxicokinetics and Hazard Identification
   • Exposure Assessment
   • Risk Assessment and Risk Communication

4. Future Issues
   • Harmonization of Excipient Standards

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