Introduction to generic drug product development / Active pharmaceutical ingredients / Analytical methods development and methods validation for solid oral dosage forms / Experimental formulation development / Scale-up, process validation, and technology transfer / Drug stability / Quality control and quality assurance / Drug product performance, in vitro / ANDA regulatory approval process / Bioequivalence and drug product assessment, in vivo / Statistical considerations for establishing bioequivalence / Scale-up, post-approval changes, and post-marketing surveillance / Outsourcing bioavailability and bioequivalence studies to contract research organizations / Legal and legislative hurdles to generic drug development, approval, and marketing