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Excipient Toxicity and Safety

Excipient Toxicity and Safety

          
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About the Book

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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    Product Details
    • ISBN-13: 9780824782108
    • Publisher: CRC Press
    • Publisher Imprint: Crc Press
    • Depth: 25
    • Language: English
    • Returnable: Y
    • Spine Width: 24 mm
    • Width: 163 mm
    • ISBN-10: 0824782100
    • Publisher Date: 10 Nov 1999
    • Binding: Hardback
    • Height: 238 mm
    • No of Pages: 392
    • Series Title: Drugs and the Pharmaceutical Sciences
    • Weight: 693 gr


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