Book: Analytical Method Development And Validation Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Details of Book: Analytical Method Development And Validation Book: Analytical Method Development And Validation
Author: Michael Swartz, Swartz Swartz, Michael Swartz
ISBN: 0824701151
ISBN-13: 9780824701154
, 978-0824701154
Binding: Paperback
Publishing Date: 1997-05-16
Publisher: Crc Press
Number of Pages: 96
Language: English