Excipient Toxicity and Safety: 1st Edition (Paperback) book cover

Excipient Toxicity and Safety

1st Edition

By Myra L. Weiner, Lois A. Kotkoskie

CRC Press

392 pages

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Paperback: 9780367399313
pub: 2019-09-19
Hardback: 9780824782108
pub: 1999-11-10
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pub: 1999-11-10
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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.

  • Table of Contents

    Introduction to Excipients

    What Are Excipients?

    Thomas A. Wheatley

    Purity of Excipients

    Dankward Jäkel 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

    About the Authors

    Weiner, Myra L.; Kotkoskie, Lois A.

    Subject Categories

    BISAC Subject Codes/Headings:
    MEDICAL / Pharmacology
    SCIENCE / Chemistry / General