Analytical Method Development and Validation (Paperback) (ISBN-13: 9780824701154)

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.

Author: Michael E. Swartz
ISBN-10: 0824701151
ISBN-13: 9780824701154
Publisher: CRC Press
Language: English
Published: 05/16/1997
Pages: 96
Format: Paperback
Weight: 0.28lbs
Size: 8.18h x 5.96w x 0.19d