商品簡介
Completey revised and updated, this second edition requires three volumes to accommodate the many changes in the science and technology associated with these products. Volume 1 covers formulation and product development, with chapters on the dosage form and its historical development. Volume 2 discusses the principles, characteristics, and operations of the processing functions of sterile drug products. Volume 3 offers comprehensive coverage of medical devices, quality assurance, and regulatory issues and explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals.
