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Excipient Toxicity and Safety (Hardcover)
Loot Price: R5,311
Discovery Miles 53 110
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Excipient Toxicity and Safety (Hardcover)
Expected to ship within 12 - 17 working days
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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.
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