Excipient Toxicity and Safety

1st Edition

Myra L. Weiner, Lois A. Kotkoskie

CRC Press
Published November 10, 1999
Reference - 392 Pages
ISBN 9780824782108 - CAT# DK4175
Series: Drugs and the Pharmaceutical Sciences

For Instructors Request Inspection Copy

USD$210.00

Add to Wish List
FREE Standard Shipping!

Summary

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.
  • Instructors

    We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption.

    Request an
    e-inspection copy

    Share this Title