Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

This book collects 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. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia.