Development and approval of combination products a regulatory perspective - Siegel, Evan B. (Hoboken, N.J. : Wiley, 2008)
Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.
Includes bibliographical references and index.
Description based on metadata supplied by the publisher and other sources.
Electronic reproduction. Santa Fe, Arg.: elibro, 2021. Available via World Wide Web. Access may be limited to eLibro affiliated libraries.
Keywords: United States. -- Food and Drug Administration; Drug approval -- United States; Biological products -- United States; Medical instruments and apparatus -- United States; Electronic books