Pharmaceutical and medical device validation by experimental design / edited by Lynn D. Torbeck. - New York : Informa Healthcare, c2007. - xvi, 251 p. : ill. ; 24 cm.

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.

9781420055696 1420055690

2007001418

GBA728906 bnb


Pharmaceutical technology--Validity--Research--Methodology.
Experimental design.
Technology, Pharmaceutical--methods.
Multivariate Analysis.
Quality Control.
Reproducibility of Results.
Research Design.
Technology, Pharmaceutical--standards.

RS192 .P468 / .P468 2007

615/.19

2007 I-023 QV 778 / P5353995 2007