Content:
List of contributors
Pages vii-viii
Introduction
Pages ix-x
Christopher M. Riley, Thomas W. Rosanske
Chapter 1 Assay validation and inter-laboratory transfer Original Research Article
Pages 3-13
Eugene McGonigle
Chapter 2 Statistical parameters and analytical figures of merit Original Research Article
Pages 15-71
Christopher M. Riley
Chapter 3 Overview of world-wide regulations Original Research Article
Pages 75-99
Ian E. Davidson
Chapter 4 Issues related to the United States v. Barr Laboratories, Inc. Original Research Article
Pages 101-117
Cathy L. Burgess
Chapter 5 Judge Wolin's interpretations of current good manufacturing practice issues contained in the Court's ruling in the United States v. Barr Laboratories Original Research Article
Pages 119-130
Richard J. Davis
Chapter 6 Bulk drug substances and finished products Original Research Article
Pages 135-167
Paul K. Hovsepian
Chapter 7 Dissolution studies Original Research Article
Pages 169-184
Thomas W. Rosanske, Cynthia K. Brown
Chapter 8 Robotics and automated workstations Original Research Article
Pages 185-208
Julie J. Tomlinson
Chapter 9 Biotechnology products Original Research Article
Pages 209-248
G. Susan Srivatsa
Chapter 10 Biological Samples Original Research Article
Pages 249-292
Krzysstof A. Selinger
Chapter 11 Analytical methods for cleaning procedures Original Research Article
Pages 293-302
Thomas M. Rossi, Ralph R. Ryall
Chapter 12 Computer systems and computer-aided validation Original Research Article
Pages 303-336
Joseph G. Liscouski
Index
Pages 339-352