includes index.

Includes bibliographical references and index.

Introduction to generic drug product development /. Leon Shargel, Izzy Kanfer -- Active pharmaceutical ingredients /. Edward M. Cohen, Lih-Yang Lin -- Analytical methods development and methods validation for solid oral dosage forms /. Quanyin Gao, Robert Vita, Dilip R. Sanvordeker -- Experimental formulation development /. Izzy Kanfer, Peter Persicaner, Roderick B. Walker -- Scale-up, process validation, and technology transfer /. Salah C. Ahmed, Venkatesh Naini, Dilip Wadgaonkar -- Drug stability /. Pranab K. Bhattacharyya -- Quality control and quality assurance /. Loren Gelber, Joan Janulis -- Drug product performance, in vitro /. Pradeep M. Sathe ... [et al.] -- ANDA regulatory approval process /. Timothy W. Ames ... [et al.] -- Bioequivalence and drug product assessment, in vivo /. Dale P. Conner, Barbara M. Davit -- Statistical considerations for establishing bioequivalence /. Sanford Bolton -- Scale-up, post-approval changes, and post-marketing surveillance /. Sadie M. Ciganek ... [et al.] -- Outsourcing bioavailability and bioequivalence studies to contract research organizations /. Patrick K. Noonan -- Legal and legislative hurdles to generic drug development, approval, and marketing /. Arthur Y. Tsien.

All age.