ABSTRACT

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

chapter 1|20 pages

What Are Excipients?

chapter 2|38 pages

Purity of Excipients

chapter 3|14 pages

History of Excipient Safety and Toxicity

chapter 4|28 pages

Regulation of Pharmaceutical Excipients

chapter 6|18 pages

Routes of Exposure: Oral

chapter 9|24 pages

Routes of Exposure: Parenteral

chapter 10|36 pages

Routes of Exposure: Other

chapter 11|16 pages

Toxicokinetics and Hazard Identification

chapter 12|22 pages

Exposure Assessment

chapter 13|16 pages

Risk Assessment and Risk Communication

chapter 14|34 pages

Harmonization of Excipient Standards