Excipient Toxicity and Safety

Myra L. Weiner, Lois A. Kotkoskie

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English

CRC Press
19 September 2019

Clinical trials; Biology, life sciences; Pharmaceutical technology

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.

By: Myra L. Weiner, Lois A. Kotkoskie
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 229mm, Width: 152mm,
Weight: 453g
ISBN: 9780367399313
ISBN 10: 0367399318
Pages: 392
Publication Date: 19 September 2019
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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

Weiner, Myra L.; Kotkoskie, Lois A.