Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
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The Pharmaceutical Regulatory Process
By Ira R. Berry
Published by Marcel Dekker Incorporated, 2004
ISBN 0203997042, 9780203997048