Description: Excipient Toxicity and Safety, Hardcover by Weiner, Myra L. (EDT); Kotkoskie, Lois A. (EDT), ISBN 0824782100, ISBN-13 9780824782108, Like New Used, Free P&P in the UK Reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients (inactive ingredients) in the United States and Europe to depict the current scientific basis for safety evaluation and risk assessment. Among the 14 contributions are discussions of the requirements and importance of purity specifications, how data generated in toxicity studies are used to identify hazards for use in drug formulations, and the difficulties of harmonization. The Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure are clarified. Annotation c. Book News, Inc., Portland, OR ()
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Book Title: Excipient Toxicity and Safety
Number of Pages: 392 Pages
Language: English
Publication Name: Excipient Toxicity and Safety
Publisher: Taylor & Francis INC International Concepts
Publication Year: 1999
Subject: Medicine
Item Height: 229 mm
Item Weight: 658 g
Type: Textbook
Author: Lois A. Kotkoskie, Myra L. Weiner
Item Width: 152 mm
Format: Hardcover