Includes bibliographical references and index.

Designing experiments for validation of quantitative methods / T. Lynn Eudey -- Validation of chemical reaction processes / Robert F. Dillard and Daniel R. Pilipauskas -- The role of designed experiments in validation and process analytical technologies / Lynn D. Torbeck and Ronald C. Branning -- Experimental design for bioassay development and validation / David M. Lansky -- Use of experimental design techniques in the qualification and validation of plasma protein manufacturing processes / Sourav Kundu -- Response surface methodology for validation of oral dosage forms / Thomas D. Murphy -- The role of designed experiments in developing and validating control plans / Wayne A. Taylor -- Efficient and effective process development work: the key to a successful validation study / Jeffrey T. Field.