内容简介：
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products-including the availability of raw materials and chemical purity. The book outlines a variety of legal, regulatory, and patent challenges presented by the brand-name pharmaceutical industry. It describes scale up, post-approval changes, and post-marketing surveillance and details the ANDA regulatory process. This second edition contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia.