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Excipient Toxicity and Safety

Excipient Toxicity and Safety

Av Lois A. Kotkoskie, Myra L. Weiner, 1999.

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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    Språk: Engelsk

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    Produktinformasjon
    Format
    Innbundet
    Utgivelsesår
    1999
    Første salgsdato
    10.11.1999
    Forlag
    CRC Press Inc
    Språk
    Engelsk
    Antall sider
    392
    Høyde
    155 mm
    Bredde
    235 mm
    Lengde
    26 mm
    Vekt
    698 g
    ISBN
    9780824782108
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