Myra L. Weiner, Lois A. Kotkoskie

Excipient Toxicity and Safety (eBook, PDF)

• Format: PDF

Produktbeschreibung

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 pr

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 388
• Erscheinungstermin: 10. November 1999
• Englisch
• ISBN-13: 9781420002270
• Artikelnr.: 54258854

Autorenporträt

Weiner, Myra L.; Kotkoskie, Lois A.

Inhaltsangabe

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