Description
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.
About the Author
Michael E. Swartz, Ira S. Krull
Reviews
Book Information
ISBN 9780824701154
Author Michael E. Swartz
Format Paperback
Page Count 96
Imprint CRC Press Inc
Publisher Taylor & Francis Inc
Weight(grams) 180g
About the Author
Michael E. Swartz, Ira S. Krull
Reviews
". . .a useful primer-type book covering validation of analytical methods. . . .recommended."
---Analyst
"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."
---INFORM
Book Information
ISBN 9780824701154
Author Michael E. Swartz
Format Paperback
Page Count 96
Imprint CRC Press Inc
Publisher Taylor & Francis Inc
Weight(grams) 180g
