Pharmaceutical and medical device validation by experimental design - Torbeck, Lynn D. (New York : Informa Healthcare, 2007)
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.
Includes bibliographical references and index.
Keywords: Pharmaceutical technology -- Validity -- Research -- Methodology; Experimental design; Technology, Pharmaceutical -- methods; Multivariate Analysis; Quality Control; Reproducibility of Results; Research Design; Technology, Pharmaceutical -- standards