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Pharmaceutical and medical device validation by experimental design / edited by Lynn D. Torbeck.

Contributor(s): Material type: TextTextPublication details: New York : Informa Healthcare, c2007.Description: xvi, 251 p. : ill. ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9781420055696
  • 1420055690
Subject(s): DDC classification:
  • 615/.19 22
LOC classification:
  • RS192 .P468 .P468 2007
NLM classification:
  • 2007 I-023
  • QV 778
Online resources:
Contents:
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.
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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.

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