书目详情:
List of contributorsIntroductionChapter 1 Assay validation and inter-laboratory transferChapter 2 Statistical parameters and analytical figures of meritChapter 3 Overview of world-wide regulationsChapter 4 Issues related to the United States v. Barr Laboratories, Inc.Chapter 5 Judge Wolin's interpretations of current good manufacturing practice issues contained in the Court's ruling in the United States v. Barr LaboratoriesChapter 6 Bulk drug substances and finished productsChapter 7 Dissolution studiesChapter 8 Robotics and automated workstationsChapter 9 Biotechnology productsChapter 10 Biological SamplesChapter 11 Analytical methods for cleaning proceduresChapter 12 Computer systems and computer-aided validationIndex
评论:

