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Excipient Toxicity and Safety
Af: Myra L. Weiner, Lois A. Kotkoskie Engelsk Paperback
SPAR
kr 98
Excipient Toxicity and Safety
Af: Myra L. Weiner, Lois A. Kotkoskie Engelsk Paperback
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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    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.
  • Produktdetaljer
    Sprog: Engelsk
    Sider: 392
    ISBN-13: 9780367399313
    Indbinding: Paperback
    Udgave:
    ISBN-10: 0367399318
    Kategori: Kliniske forsøg
    Udg. Dato: 19 sep 2019
    Længde: 0mm
    Bredde: 229mm
    Højde: 152mm
    Oplagsdato: 19 sep 2019
    Forfatter(e) Myra L. Weiner, Lois A. Kotkoskie


    Kategori Kliniske forsøg


    Sprog Engelsk


    Indbinding Paperback


    Sider 392


    Udgave


    Længde 0mm


    Bredde 229mm


    Højde 152mm

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