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Excipient Toxicity and Safety
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Excipient Toxicity and Safety Hardcover - 1999

by Myra L. Weiner; Lois A. Kotkoskie


From the publisher

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.
  • First line

    There are several definitions for an excipient.

    Details

    • Title Excipient Toxicity and Safety
    • Author Myra L. Weiner; Lois A. Kotkoskie
    • Binding Hardcover
    • Edition International Ed
    • Pages 392
    • Volumes 1
    • Language ENG
    • Publisher CRC Press, New York
    • Date 1999-11-10
    • ISBN 9780824782108 / 0824782100
    • Weight 1.32 lbs (0.60 kg)
    • Dimensions 9.36 x 6.42 x 0.93 in (23.77 x 16.31 x 2.36 cm)
    • Library of Congress subjects Excipients - Toxicology
    • Library of Congress Catalog Number 99051474
    • Dewey Decimal Code 615.19
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    Excipient Toxicity and Safety
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    Excipient Toxicity and Safety

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    Excipient Toxicity and Safety

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