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Excipient Toxicity and Safety
Af: Myra L. Weiner, Lois A. Kotkoskie Engelsk Paperback
SPAR
kr 103
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


    Udg. Dato 19 sep 2019


    Oplagsdato 19 sep 2019

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