Excipient toxicity and safety

edited by Myra L. Weiner, Lois A. Kotkoskie

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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[目次]

  • Introduction to Excipients What Are Excipients? Thomas A. Wheatley Purity of Excipients Dankward Jakel and Martin Keck History of Excipient Safety and Toxicity Charles L. Winek Regulation of Pharmaceutical Excipients Christopher C. DeMerlis Safety Evaluation of Pharmaceutical Excipients Development of Safety Evaluation Guidelines Joseph F. Borzelleca and Myra L. Weiner Routes of Exposure: Oral Lois A. Kotkoskie Routes of Exposure: Topical and Transdermal Matthew J. Cukierski and Alice E. Loper Routes of Exposure: Inhalation and Intranasal Charmille B. Tamulinas and Chet L. Leach Routes of Exposure: Parenteral David B. Mitchell Routes of Exposure: Other Carol S. Auletta Risk Assessment of Excipients Toxicokinetics and Hazard Identification Frank M. Sullivan and Susan M. Barlow Exposure Assessment David J. George and Annette M. Shipp Risk Assessment and Risk Communication Anthony D. Dayan Future Issues Harmonization of Excipient Standards Zak T. Chowhan

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この本の情報

書名 Excipient toxicity and safety
著作者等 Kotkoskie Lois A.
Kotkoskie, Lois A.
Weiner, Myra L.
Weiner Myra L.
シリーズ名 Drugs and the pharmaceutical sciences
出版元 Dekker
刊行年月 c2000
ページ数 x, 370 p.
大きさ 24 cm
ISBN 0824782100
NCID BA44302918
※クリックでCiNii Booksを表示
言語 英語
出版国 アメリカ合衆国
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