The Pharmaceutical Regulatory Process

• Other Authors: Berry, Ira R. 1942- (Editor)
• Format: Book
• Language: English
• Published: New York MARCEL DEKKER 2005
• Series: Drugs and the pharmaceutical sciences volume 144
• Subjects: Guideline adherence > legislation and jurisprudence > United States; Pharmaceutical preparations > standards > United States; Drug and narcotic control > legislation and jurisprudence > United States
• Online Access: Click Here to View Status and Holdings.
• Physical Description: xiii, 711 pages illustrations 24 cm
• Bibliography: Includes bibliographical references and index
• ISBN: 0824754646; 9780824754648

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